Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "DWJ1622" and Co-administration of "DWC202313" and "DWC202314" in Healthy Volunteers

This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: DWJ1622; Drug: DWC202313, DWC202314

Detailed Description

This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study to evaluate the pharmacokinetics and safety profiles of DWJ1622, DWC202313, and DWC202314 in healthy volunteers under fed conditions. Subjects will be randomized to receive either DWJ1622 or the co-administration of DWC202313 and DWC202314 in different sequences across two study periods with an appropriate washout period.

The primary pharmacokinetic endpoints include the maximum observed plasma concentration (Cmax) and the area under the plasma concentration-time curve to the last measurable concentration (AUClast) of each study drug. Secondary endpoints include the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), the ratio of AUClast to AUCinf (AUClast/AUCinf), the time to reach maximum plasma concentration (Tmax), and the terminal elimination half-life (t1/2). Safety will be evaluated based on adverse events and clinical laboratory tests.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: SHIN; Phone Number: 825508858; Email: hbshin028@daewoong.co.kr

Study Locations

• South Korea
  • Gwanak-gu
    • Seoul, Gwanak-gu, South Korea, 08779
      • Recruiting
      • H Plus Yangji Hospital
      • Contact: Bae; Phone Number: 8218778875

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWJ1622	Drug: DWJ1622; DWJ1622 (single oral dose) is administered in accordance with the study protocol.; Drug: DWC202313, DWC202314; DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.
Experimental: DWC202313, DWC202314	Drug: DWJ1622; DWJ1622 (single oral dose) is administered in accordance with the study protocol.; Drug: DWC202313, DWC202314; DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Cmax of DWJ1622 and DWC202313, DWC202314	At pre-dose (0 hours), and post-dose 1 to 72 hours.
AUClast	AUClast of DWJ1622 and DWC202313, DWC202314	Time Frame: At pre-dose (0 hours), and post-dose 1 to 72 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	AUCinf of DWJ1622 and DWC202313, DWC202314	At pre-dose (0 hours), and post-dose 1 to 72 hours.
AUClast/AUCinf	AUClast/AUCinf of DWJ1622 and DWC202313, DWC202314	At pre-dose (0 hours), and post-dose 1 to 72 hours.
Tmax	Tmax of DWJ1622 and DWC202313, DWC202314	At pre-dose (0 hours), and post-dose 1 to 72 hours.

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1622103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No