Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWC202312; Drug: DWJ1567

Study type: Interventional

Funder types: Industry

Identifiers

NCT06109259

DWJ1567101

Details and patient eligibility

About

This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers

Full description

The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.

Enrollment: 44 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 19 year old

Exclusion criteria

• Galactose intolerance
• Lapp lactase deficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

DWJ1567

Experimental group

Description:

DWJ1567

Treatment:

Drug: DWJ1567

DWC202312

Active Comparator group

Description:

DWC202312

Treatment:

Drug: DWC202312