Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

August 28, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers

This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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 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:

  • Pancreatitis
  • Diabetic ketoacidosis

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: Intervention: DWJ1558
Drug: DWJ1558
DWJ1558
Experimental: Intervention: DWC202310 and DWC202311
Drug: DWC202310 and DWC202311
Co-administration of DWC202310 and DWC202311

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,ss of DWJ1558
Time Frame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558
At pre-dose (0 hour), and post-dose 1 to 72 hour.
AUCt of DWJ1558
Time Frame: At pre-dose (0 hour), and post-dose 1 to 72 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558
At pre-dose (0 hour), and post-dose 1 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 (Actual)

August 17, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

August 20, 2023

First Submitted That Met QC Criteria

August 20, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DWJ1558101

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.

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