The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
- Registration Number
- NCT05321732
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention: DWP16001 A mg + DWC202010 B mg DWP16001 - Intervention: DWP16001 A mg + DWC202010 B mg DWP202010 - Intervention: DWC202010 B mg DWP202010 - Intervention: DWP16001 A mg DWP16001 -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 Before IP administration and post-dose up to 24 hours Peak Plasma Concentration (Cmax,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6 Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6 Peak Plasma Concentration (Cmax,ss) of DWC202010 Before IP administration and post-dose up to 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of