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
ConditionsDrug-drug Interaction
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
Investigators
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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