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

October 29, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung-Hyun Kang, MD, Ph D
  • Phone Number: 070-4665-9490
  • Email: juspa@newyjh.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Over 19 year old

Exclusion Criteria:

  • Galactose intolerance
  • Lapp lactase deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWJ1567
Drug: DWJ1567
One tablet of DWJ1567
Active Comparator: DWC202312
Drug: DWC202312
One tablet of DWC202312

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour
At pre-dose (0 hour), and post-dose 0 to 72 hour
Tmax of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour
At pre-dose (0 hour), and post-dose 0 to 72 hour
AUCt/AUCinf of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour
At pre-dose (0 hour), and post-dose 0 to 72 hour
t1/2 of DWJ1567 and DWC202312
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour
At pre-dose (0 hour), and post-dose 0 to 72 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 6, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DWJ1567101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe