Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions

An Open-label, Randomized, Fasting, 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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07260851

Enrollment

Registered

2025-12-03

Start date

2025-11-05

Completion date

2026-05-30

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Detailed description

This is an open-label, randomized, oral, single-dose, 2-sequence, 2-period, crossover Phase 1 study designed to compare the pharmacokinetics and safety profiles of DWJ1622 with the co-administration of DWC202313 and DWC202314 in healthy volunteers under fasting 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.

Interventions

DRUGDWJ1622

DWJ1622 (single oral dose) is administered in accordance with the study protocol.

DRUGDWC202313, DWC202314

DWC202313, DWC202314(single oral dose) is administered in accordance with the study protocol.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

Primary ContactSHIN

hbshin028@daewoong.co.kr825508858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026