PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-09-30

Brief Summary

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PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A(RT)

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

Group Type EXPERIMENTAL

DWJ1511

Intervention Type DRUG

Test drug: DWJ1511

DWC202501

Intervention Type DRUG

Comparator: DWC202501

B(TR)

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

Group Type ACTIVE_COMPARATOR

DWJ1511

Intervention Type DRUG

Test drug: DWJ1511

DWC202501

Intervention Type DRUG

Comparator: DWC202501

Interventions

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DWJ1511

Test drug: DWJ1511

Intervention Type DRUG

DWC202501

Comparator: DWC202501

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes