Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Period 1; Drug: Period 4; Drug: Period 3; Drug: Period 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06592495

DW_DWJ1589101

Details and patient eligibility

About

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

Full description

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Enrollment: 52 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 19 year old
• Healthy adult volunteers

Exclusion criteria

• with a history of mental disorder
• For female volunteers, those who are suspected of being pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Sequence A: RTRT

Experimental group

Description:

T: DWJ1589 R: DWC202315

Treatment:

Drug: Period 2

Drug: Period 3

Drug: Period 4

Drug: Period 1

Sequence B: TRTR

Experimental group

Description:

T: DWJ1589 R: DWC202315

Treatment:

Drug: Period 2

Drug: Period 3

Drug: Period 4

Drug: Period 1