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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWP16001; Drug: DWP202010

Study type: Interventional

Funder types: Industry

Identifiers

NCT05321732

DW_DWP306001101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Intervention: DWP16001 A mg

Experimental group

Treatment:

Drug: DWP16001

Intervention: DWC202010 B mg

Experimental group

Treatment:

Drug: DWP202010

Intervention: DWP16001 A mg + DWC202010 B mg

Experimental group

Treatment:

Drug: DWP16001

Drug: DWP202010