NCT05465668

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DWP16001 Drug A	DWP16001 Drug A
DRUG	DWP16001 Drug C	DWP16001 Drug C

Timeline

• Start date: 2022-07-22
• Primary completion: 2022-08-16
• Completion: 2022-11-22
• First posted: 2022-07-20
• Last updated: 2023-01-31

Locations

1 site across 1 country: South Korea