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NCT05321732 Clinical Trial

The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05321732
Other study ID # DW_DWP306001101
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date December 10, 2021
Est. completion date August 2022

Study information
Verified date January 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

Description:

The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 24
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWP16001
DWP16001 A mg
• DWP202010
DWP202010 B mg

Locations
Country Name City State
Korea, Republic of Yonsei University Severance Hospital Seoul

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6
Primary Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6
Primary Peak Plasma Concentration (Cmax,ss) of DWC202010 Before IP administration and post-dose up to 24 hours
Primary Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 Before IP administration and post-dose up to 24 hours
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