Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Phase 1

Completed

• Conditions: Drug-drug Interaction
• Interventions: Drug: DWP14012 + DWC202005, after multiple doses of DWP14012; Drug: DWC202005, alone; Drug: DWP14012 + DWC202005

• Registration Number: NCT04328766
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Study Start: 2020-09-06
• Primary Completion: 2020-11-21
• Study Completion: 2020-11-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 Cohort C	DWP14012 + DWC202005, after multiple doses of DWP14012	-
DWP14012 Cohort A	DWC202005, alone	-
DWP14012 Cohort B	DWP14012 + DWC202005	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma drug concentration-time curve	upto 48 hours postdose	AUClast of DWC202005
Peak Plasma Concentration (Cmax)	upto 48 hours postdose	Cmax of DWC202005
Incidence of Treatment-Emergent Adverse Events	up to 19 days

Trial Locations

Locations (1)

Nucleus Network (QPharm); 🇦🇺 Queensland, Australia