NCT06109259

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers

An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers

Detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DWJ1567	One tablet of DWJ1567
DRUG	DWC202312	One tablet of DWC202312

Timeline

• Start date: 2023-11-06
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-10-31
• Last updated: 2023-10-31

Locations

1 site across 1 country: South Korea