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Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers

NCT ID: NCT06119945

Last Updated: 2023-11-07

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

2023-11-09

Study Completion Date

2023-12-31

Brief Summary

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This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

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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 DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.

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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DWJ1568

DWJ1568

Group Type EXPERIMENTAL

DWJ1568

Intervention Type DRUG

One tablet of DWJ1568

DWC202215

DWC202215

Group Type ACTIVE_COMPARATOR

DWC202215

Intervention Type DRUG

One tablet of DWC202215

Interventions

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DWJ1568

One tablet of DWJ1568

Intervention Type DRUG

DWC202215

One tablet of DWC202215

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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MunJung Bae, MD, Ph D

Role: CONTACT

[email protected]
070-4665-9174

Facility Contacts

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MunJeong Bae, MD, Ph D.

Role: primary

[email protected]
070-4665-9174

Other Identifiers

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DWJ1568101

Identifier Type: -

Identifier Source: org_study_id

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