The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

April 4, 2022 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Study Type

Interventional

Enrollment (Anticipated)

24

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

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention: DWP16001 A mg
Drug: DWP16001
DWP16001 A mg
EXPERIMENTAL: Intervention: DWC202010 B mg
Drug: DWP202010
DWP202010 B mg
EXPERIMENTAL: Intervention: DWP16001 A mg + DWC202010 B mg
Drug: DWP16001
DWP16001 A mg
Drug: DWP202010
DWP202010 B mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax,ss) of DWP16001
Time Frame: Before IP administration of Day 1, Day 5, and Day 6
Before IP administration of Day 1, Day 5, and Day 6
Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001
Time Frame: Before IP administration of Day 1, Day 5, and Day 6
Before IP administration of Day 1, Day 5, and Day 6
Peak Plasma Concentration (Cmax,ss) of DWC202010
Time Frame: Before IP administration and post-dose up to 24 hours
Before IP administration and post-dose up to 24 hours
Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
Time Frame: Before IP administration and post-dose up to 24 hours
Before IP administration and post-dose up to 24 hours

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)

December 10, 2021

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (ACTUAL)

April 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWP306001101

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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Locations

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