A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- DWP16001
- Conditions
- Healthy Volunteers
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention: DWP16001 A mg
Intervention: DWP16001
Intervention: DWC202010 B mg
Intervention: DWP202010
Intervention: DWP16001 A mg + DWC202010 B mg
Intervention: DWP16001
Intervention: DWP16001 A mg + DWC202010 B mg
Intervention: DWP202010
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
Time Frame: Before IP administration and post-dose up to 24 hours
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