Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

March 25, 2021 updated by: Daewoong Pharmaceutical Co. LTD.

An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

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

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Chonbuk National University Hospital

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:

  • Age 19 to 55 years
  • Healthy Adult

Exclusion Criteria:

  • Non-Healthy

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: group1
subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition
Drug: DWJ1451
DWC202008 DWC202009
EXPERIMENTAL: group2
subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition
Drug: DWJ1451
DWC202008 DWC202009

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter of DWJ1451:AUC0-t
Time Frame: 0 - 72 hours after dosing
Area under the plasma xonxentration-time curve from time 0 to t
0 - 72 hours after dosing
Pharmacokinetic parameter of DWJ1451:Cmax
Time Frame: 0 - 72 hours after dosing
Maximum plasma drug concentration
0 - 72 hours after dosing

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)

March 13, 2021

Primary Completion (ACTUAL)

March 13, 2021

Study Completion (ANTICIPATED)

April 2, 2021

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (ACTUAL)

March 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DW_DWJ1451102

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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