NCT05500898

Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults

A Phase I Clinical Trial to Evaluate the Safety and Drug Interactions Between DWP16001 and in Combination With DWC202204 and DWC202205 in Healthy Adult Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202204 and DWC202205 alone or in combination in healthy male adults.

Detailed description

\* Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule. After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP16001	Tablets, Oral, multiple doses of DWP16001
DRUG	DWC202204+DWC202205	Tablets, Oral, multiple doses of DWC202204 and DWC202205 in combination
DRUG	DWP16001+DWC202204+DWC202205	Tablets, Oral, DWP16001 , multiple doses of DWC202204 and DWC202205 in combination

Timeline

• Start date: 2022-08-26
• Primary completion: 2022-10-31
• Completion: 2023-02-28
• First posted: 2022-08-15
• Last updated: 2022-08-15