Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

August 13, 2021 updated by: Daewoong Pharmaceutical Co. LTD.

An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Australia
      • Queensland, Australia, 78
        • Nucleus Network (QPharm)

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
  • Capable of understanding provided information and complying with protocol requirements
  • Provide written informed consent to participate in the study

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWP14012 Cohort A
Drug: DWC202005, alone
DWC202005, as a single dose
Experimental: DWP14012 Cohort B
Drug: DWP14012 + DWC202005
DWP14012 and DWC202005, as a single dose
Experimental: DWP14012 Cohort C
Drug: DWP14012 + DWC202005, after multiple doses of DWP14012
DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma drug concentration-time curve
Time Frame: upto 48 hours postdose
AUClast of DWC202005
upto 48 hours postdose
Peak Plasma Concentration (Cmax)
Time Frame: upto 48 hours postdose
Cmax of DWC202005
upto 48 hours postdose
Incidence of Treatment-Emergent Adverse Events
Time Frame: up to 19 days
up to 19 days

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)

September 6, 2020

Primary Completion (Actual)

November 21, 2020

Study Completion (Actual)

November 21, 2020

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWP14012106

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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