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

NCT ID: NCT07260851

Last Updated: 2025-12-17

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers

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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DWJ1622

Group Type EXPERIMENTAL

DWJ1622

Intervention Type DRUG

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

DWC202313, DWC202314

Intervention Type DRUG

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

DWC202313, DWC202314

Group Type EXPERIMENTAL

DWJ1622

Intervention Type DRUG

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

DWC202313, DWC202314

Intervention Type DRUG

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

Interventions

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DWJ1622

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

Intervention Type DRUG

DWC202313, DWC202314

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H Plus YANGJI Hospital

Seoul, Gwanak-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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SHIN

Role: CONTACT

[email protected]
825508858

Facility Contacts

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Bae

Role: primary

8218778875

Other Identifiers

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DW_DWJ1622102

Identifier Type: -

Identifier Source: org_study_id