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A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

NCT ID: NCT02502721

Last Updated: 2015-08-25

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

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Detailed Description

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This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Conditions

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Healthy

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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Part A

To study effect of DWC20151 on DWC20152 PK

Group Type EXPERIMENTAL

DWC20151

Intervention Type DRUG

Part B

To study effect of DWC20152 on DWC20151 PK

Group Type EXPERIMENTAL

DWC20152

Intervention Type DRUG

Interventions

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DWC20151

Intervention Type DRUG

DWC20152

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects (18\~55 years)

Exclusion Criteria

* Who has allergy to investigational product
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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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Jinah Jung

Role: PRINCIPAL_INVESTIGATOR

Busan paik hospital

Locations

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Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DWJ1373001

Identifier Type: -

Identifier Source: org_study_id

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