Skip to main content
OpenTrials
Completed

NCT Number: NCT04328766

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug-drug Interaction

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network (QPharm)

Queensland, 78, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWC202005, alone

Drug

DWC202005, as a single dose

DWP14012 + DWC202005

Drug

DWP14012 and DWC202005, as a single dose

DWP14012 + DWC202005, after multiple doses of DWP14012

Drug

DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

Primary outcomes

  1. Area under the plasma drug concentration-time curve

    Time frame: upto 48 hours postdose

    AUClast of DWC202005

  2. Peak Plasma Concentration (Cmax)

    Time frame: upto 48 hours postdose

    Cmax of DWC202005

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: up to 19 days

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.