This is an open-label, randomized, single-dose, parallel group study. The objectives of this study are to assess pharmacokinetics of oxycodone and naloxone from oxycodone/naloxone (OXN) prolonged release (PR) tablet 5/2.5 mg (OXN 5/2.5) and 20/10 mg (OXN 20/10) in Chinese patients with moderate to severe chronic non-malignant pain.
It will be conducted to assess the pharmacokinetics of OXN 5/2.5 and OXN 20/10 tablets. Subjects will be allocated to a sequence of two strength group in accordance with a random allocation schedule (RAS) in a 1:1 ratio. Subjects will attend a screening visit within 14 days of the first (OXN) dosing day (Day 1). Eligible subjects will then check into the study unit on the day before OXN dosing (Day -2). Subjects will be administered their OXN dose the next 2 morning (Day 1), following an overnight fast.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
AUC0-48hr of Noroxycodone Plasma Concentration.
AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.
AUC0-t of Noroxycodone Plasma Concentration
AUC0-t of Noroxycodone plasma concentration.Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed .(If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf \< 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda\_z) will not be adopted and will not be included in any statistical analysis. )
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.
AUC_%Extrap of Noroxycodone Plasma Concentration
AUC\_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Noroxycodone Plasma Concentration
AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Noroxycodone Plasma Concentration
Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
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Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of Noroxycodone Plasma Concentration
Lambda\_z of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of Noroxycodone Plasma Concentration
T1/2 of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of Noroxycodone Plasma Concentration
Tmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of Noroxymorphone Plasma Concentration
AUC0-48hr of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of Noroxymorphone Plasma Concentration
AUC0-t of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of Noroxymorphone Plasma Concentration
AUC\_%Extrap of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Noroxymorphone Plasma Concentration
AUCinf of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Noroxymorphone Plasma Concentration
Cmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of Noroxymorphone Plasma Concentration
Lambda\_z of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of Noroxymorphone Plasma Concentration
T1/2 of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of Noroxymorphone Plasma Concentration
Tmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of Oxycodone Plasma Concentration
AUC0-48hr of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of Oxycodone Plasma Concentration
AUC0-t of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of Oxycodone Plasma Concentration
AUC\_%Extrap of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Oxycodone Plasma Concentration
AUCinf of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Oxycodone Plasma Concentration
Cmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of Oxycodone Plasma Concentration
Lambda\_z of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of Oxycodone Plasma Concentration
T1/2 of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of Oxycodone Plasma Concentration
Tmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of Oxymorphone Plasma Concentration
AUC0-48hr of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of Oxymorphone Plasma Concentration
AUC0-t of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of Oxymorphone Plasma Concentration
AUC\_%Extrap of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Oxymorphone Plasma Concentration
AUCinf of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Oxymorphone Plasma Concentration
Cmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of Oxymorphone Plasma Concentration
Lambda\_z of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of Oxymorphone Plasma Concentration
T1/2 of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of Oxymorphone Plasma Concentration
Tmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of 6-B-Naloxol Plasma Concentration
AUC0-48hr of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of 6-B-Naloxol Plasma Concentration
AUC0-t of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of 6-B-Naloxol Plasma Concentration
AUC\_%Extrap of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of 6-B-Naloxol Plasma Concentration
AUCinf of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of 6-B-Naloxol Plasma Concentration
Cmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of 6-B-Naloxol Plasma Concentration
Lambda\_z of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of 6-B-Naloxol Plasma Concentration
T1/2 of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of 6-B-Naloxol Plasma Concentration
Tmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of NLLG Plasma Concentration
AUC0-48hr of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of NLLG Plasma Concentration
AUC0-t of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of NLLG Plasma Concentration
AUC\_%Extrap of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of NLLG Plasma Concentration
AUCinf of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of NLLG Plasma Concentration
Cmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of NLLG Plasma Concentration
Lambda\_z of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of NLLG Plasma Concentration
T1/2 of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of NLLG Plasma Concentration
Tmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of NLXG Plasma Concentration
AUC0-48hr of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of NLXG Plasma Concentration
AUC0-t of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of NLXG Plasma Concentration
AUC\_%Extrap of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of NLXG Plasma Concentration
AUCinf of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of NLXG Plasma Concentration
Cmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of NLXG Plasma Concentration
Lambda\_z of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of NLXG Plasma Concentration
T1/2 of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of NLXG Plasma Concentration
Tmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-48hr of Naloxone Plasma Concentration
AUC0-48hr of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC0-t of Naloxone Plasma Concentration
AUC0-t of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUC_%Extrap of Naloxone Plasma Concentration
AUC\_%Extrap of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
AUCinf of Naloxone Plasma Concentration
AUCinf of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Cmax of Naloxone Plasma Concentration
Cmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Lambda_z of Naloxone Plasma Concentration
Lambda\_z of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
T1/2 of Naloxone Plasma Concentration
T1/2 of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.
Tmax of Naloxone Plasma Concentration
Tmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.
Time frame: Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.