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NCT06109259 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06109259
Other study ID # DWJ1567101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 6, 2023
Est. completion date December 2023

Study information
Verified date October 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact Seung-Hyun Kang, MD, Ph D
Phone 070-4665-9490
Email juspa@newyjh.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Over 19 year old Exclusion Criteria: - Galactose intolerance - Lapp lactase deficiency

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWJ1567
One tablet of DWJ1567
• DWC202312
One tablet of DWC202312

Locations
Country Name City State
Korea, Republic of H Plus YANGJI Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour.
Primary AUCt of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour.
Secondary AUCinf of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour
Secondary Tmax of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour
Secondary AUCt/AUCinf of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour
Secondary t1/2 of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour
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