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Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers

NCT ID: NCT06109259

Last Updated: 2023-10-31

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2023-12-31

Brief Summary

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This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers

Detailed Description

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The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.

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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DWJ1567

DWJ1567

Group Type EXPERIMENTAL

DWJ1567

Intervention Type DRUG

One tablet of DWJ1567

DWC202312

DWC202312

Group Type ACTIVE_COMPARATOR

DWC202312

Intervention Type DRUG

One tablet of DWC202312

Interventions

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DWJ1567

One tablet of DWJ1567

Intervention Type DRUG

DWC202312

One tablet of DWC202312

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Over 19 year old

Exclusion Criteria

* Galactose intolerance
* Lapp lactase deficiency
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, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung-Hyun Kang, MD, Ph D

Role: CONTACT

Phone: 070-4665-9490

Email: [email protected]

Facility Contacts

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Seung-Hyun Kang

Role: primary

Other Identifiers

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DWJ1567101

Identifier Type: -

Identifier Source: org_study_id