This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.
The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Yonsei University Severance Hospital
Seoul, South Korea
Peak Plasma Concentration (Cmax,ss) of DWP16001
Time frame: Before IP administration of Day 1, Day 5, and Day 6
Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001
Time frame: Before IP administration of Day 1, Day 5, and Day 6
Peak Plasma Concentration (Cmax,ss) of DWC202010
Time frame: Before IP administration and post-dose up to 24 hours
Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
Time frame: Before IP administration and post-dose up to 24 hours
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