PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: DWC202501; Drug: DWJ1511

Study type: Interventional

Funder types: Industry

Identifiers

NCT07144176

DW_DWJ1511101

Details and patient eligibility

About

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Full description

This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. 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: 60 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female participants aged ≥19 years and <65 years at the time of screening
• Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight [kg] / height [m]²)

Exclusion criteria

• Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
• Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
• Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A(RT)

Experimental group

Description:

30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2

Treatment:

Drug: DWJ1511

Drug: DWC202501

B(TR)

Active Comparator group

Description:

30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2

Treatment:

Drug: DWJ1511

Drug: DWC202501