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NCT04328766 Clinical Trial

Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Drug-drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04328766
Other study ID # DW_DWP14012106
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 6, 2020
Est. completion date November 21, 2020

Study information
Verified date August 2021
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date November 21, 2020
Est. primary completion date November 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWC202005, alone
DWC202005, as a single dose
• DWP14012 + DWC202005
DWP14012 and DWC202005, as a single dose
• DWP14012 + DWC202005, after multiple doses of DWP14012
DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

Locations
Country Name City State
Australia Nucleus Network (QPharm) Queensland

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Australia, 

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