PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: DWC202506; Drug: DWJ1445

Study type: Interventional

Funder types: Industry

Identifiers

NCT07256600

DW_DWJ1445102

Details and patient eligibility

About

A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults

Full description

This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.

Enrollment: 70 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with a body mass index (BMI) between 18 and 30 kg/m²
• Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
• Subjects who agree to use a medically acceptable method of contraception

Exclusion criteria

• Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
• Subjects with a history of gastrointestinal surgery that may affect drug absorption
• Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

A(RT)

Experimental group

Description:

35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2

Treatment:

Drug: DWJ1445

Drug: DWC202506

B(TR)

Experimental group

Description:

35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2

Treatment:

Drug: DWJ1445

Drug: DWC202506