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RECRUITINGPHASE1

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers

NCT07144176•Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

Summary

Detailed 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.

Eligibility

Age

19 - 64 years

Sex

ALL

Healthy Volunteers

Yes

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).

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Key Dates

Start Date

September 1, 2025

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Healthy Subjects

Interventions

DWJ1511

DRUG

DWC202501

DRUG

Contacts

Kang

CONTACT

82) 070-4665-9490 juspa@newyjh.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

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