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Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

NCT ID: NCT06592495

Last Updated: 2024-09-23

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

Brief Summary

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This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

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Detailed Description

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The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

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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Sequence A: RTRT

T: DWJ1589 R: DWC202315

Group Type EXPERIMENTAL

Period 1

Intervention Type DRUG

DWJ1589 or DWC202315

Period 2

Intervention Type DRUG

DWJ1589 or DWC202315

Period 3

Intervention Type DRUG

DWJ1589 or DWC202315

Period 4

Intervention Type DRUG

DWJ1589 or DWC202315

Sequence B: TRTR

T: DWJ1589 R: DWC202315

Group Type EXPERIMENTAL

Period 1

Intervention Type DRUG

DWJ1589 or DWC202315

Period 2

Intervention Type DRUG

DWJ1589 or DWC202315

Period 3

Intervention Type DRUG

DWJ1589 or DWC202315

Period 4

Intervention Type DRUG

DWJ1589 or DWC202315

Interventions

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Period 1

DWJ1589 or DWC202315

Intervention Type DRUG

Period 2

DWJ1589 or DWC202315

Intervention Type DRUG

Period 3

DWJ1589 or DWC202315

Intervention Type DRUG

Period 4

DWJ1589 or DWC202315

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

Principal Investigators

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KANG, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Central Contacts

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SHIN, CPL

Role: CONTACT

02-550-8858

Other Identifiers

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DW_DWJ1589101

Identifier Type: -

Identifier Source: org_study_id

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