Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

NCT ID: NCT06010589

Last Updated: 2023-08-30

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2024-01-31

Brief Summary

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This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Detailed Description

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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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Intervention: DWJ1558

Group Type EXPERIMENTAL

DWJ1558

Intervention Type DRUG

DWJ1558

Intervention: DWC202310 and DWC202311

Group Type EXPERIMENTAL

DWC202310 and DWC202311

Intervention Type DRUG

Co-administration of DWC202310 and DWC202311

Interventions

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DWJ1558

DWJ1558

Intervention Type DRUG

DWC202310 and DWC202311

Co-administration of DWC202310 and DWC202311

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* over 19 year old

Exclusion Criteria

* Pancreatitis
* Diabetic ketoacidosis
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

Countries

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South Korea

Other Identifiers

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DWJ1558101

Identifier Type: -

Identifier Source: org_study_id

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