NCT05321732

The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DWP16001	DWP16001 A mg
DRUG	DWP202010	DWP202010 B mg

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: South Korea