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Clinical Trials/NCT04328766
NCT04328766
Completed
Phase 1

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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country36 target enrollmentSeptember 6, 2020

Overview

Phase
Phase 1
Intervention
DWC202005, alone
Conditions
Drug-drug Interaction
Sponsor
Daewoong Pharmaceutical Co. LTD.
Enrollment
36
Locations
1
Primary Endpoint
Area under the plasma drug concentration-time curve
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 6, 2020
End Date
November 21, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

DWP14012 Cohort A

Intervention: DWC202005, alone

DWP14012 Cohort B

Intervention: DWP14012 + DWC202005

DWP14012 Cohort C

Intervention: DWP14012 + DWC202005, after multiple doses of DWP14012

Outcomes

Primary Outcomes

Area under the plasma drug concentration-time curve

Time Frame: upto 48 hours postdose

AUClast of DWC202005

Peak Plasma Concentration (Cmax)

Time Frame: upto 48 hours postdose

Cmax of DWC202005

Incidence of Treatment-Emergent Adverse Events

Time Frame: up to 19 days

Study Sites (1)

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