to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
QD, PO for 7days
Chungbuk Ntional University Hospital
Cheongju-si, South Korea
RECRUITINGPrimary Pharmacokinetic Endpoint
AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Primary Pharmacodynamic Endpoint
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Time frame: 24 hours after multiple dose for 7 days compared to baseline
(1) Secondary Pharmacokinetic Endpoint
Cmax,ss Evaluation after multiple dose -Cmax,ss: Maximum concentration of drug in plasma
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Tmax,ss Evaluation after multiple dose -Tmax,ss: Time to maximum plasma concentration
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
t1/2ss Evaluation after multiple dose -t1/ss: Terminal elimination half life in steady state
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
CLss/F Evaluation after multiple dose -CLss/F: Apparent Clearance in steady-state
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
(1) Secondary Pharmacokinetic Endpoint
Vzss/F Evaluation after multiple dose -Vzss/F: Apparent Volume of Distribution at steady state
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
R Evaluation after multiple dose -R: Accumulation ratio
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
PTF Evaluation after multiple dose -PTF: Peak to Trough Fluctuation
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Cmax Evaluation after single dose -Cmax: Maximum concentration of drug in plasma
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
AUC0-t Evaluation after single dose -AUC0-t: Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Tmax Evaluation after single dose -Tmax: Time to maximum plasma concentration
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
t1/2 Evaluation after single dose -t1/2: Terminal elimination half-life
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
CL/F Evaluation after single dose -CL/F: Apparent Clearance
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Vz/F Evaluation after single dose -Vz/F: Apparent Volume of Distribution
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacodynamic Endpoint
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose
Time frame: 24 hours after first dose compared to baseline
(2) Secondary Pharmacodynamic Endpoint
Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose
Time frame: 24 hours after first dose and multiple dose for 7 days