NCT05192395

A Crossover Study of DWJ1525 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers

A Crossover, Randomized, Open-label, Comparison Study Between DWJ1525 and the Concomitant Use of DWP16001 and DWC202101 to Evaluate the Safety and Pharmacokinetic Properties in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Four-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of DWJ1525 and the Co-administration of DWP16001 and DWC202101 for Healthy Subjects in Fed and Fasted State

Detailed description

A single dose of the test (T) and two of the reference (R) products will be administered to the study subjects, according to a randomized, open-label, single oral dosing, two-sequence, and four-period crossover for healthy subjects in fed and fasted state study design. A wash-out interval of at least 7 days will elapse between the each administrations. The three investigational products will be administered with 150 mL of still mineral water on day 1 of the four study periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWJ1525	DWJ1525
DRUG	DWP16001	DWP16001
DRUG	DWC202101	DWC202101

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2022-01-14
• Last updated: 2022-07-11

Locations

1 site across 1 country: South Korea