The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone nasal spray following a 10 hour fast.
Participants received naloxone HCl IV injection following a 10 hour fast.
Worldwide Clinical Trials
San Antonio, Texas, United States
Area Under the Curve From Time 0 to the Last Measured Concentration (AUC0-t) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
AUC Extrapolated to Infinity (AUC0-inf) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) for Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Plasma Concentrations of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 2 hours post-dose
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Participants received naloxone HCl IM injection following a 10 hour fast.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A serious AE (SAE) is any AE that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention.
Time frame: Day 1 to Day 14