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Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

NCT ID: NCT03016494

Last Updated: 2017-01-10

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Brief Summary

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The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test/Reference Drug

DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.

Group Type EXPERIMENTAL

Co-administration of DWC20155 and DWC20156

Intervention Type DRUG

DWJ1386 Tab.

Intervention Type DRUG

Reference/Test Drug

co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.

Group Type EXPERIMENTAL

Co-administration of DWC20155 and DWC20156

Intervention Type DRUG

DWJ1386 Tab.

Intervention Type DRUG

Interventions

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Co-administration of DWC20155 and DWC20156

Intervention Type DRUG

DWJ1386 Tab.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI≥18.5 and ≤27.0 kg/m2
* No clinically significant findings
* Age 19-55 years at screening

Exclusion Criteria

* Who has allergy to investigational product
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 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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Busan Paik Hospital

Busan, Busanjin-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Daewoong Clinical

Role: CONTACT

82-2-550-8106

Facility Contacts

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Jae-Gook Shin, Professor

Role: primary

82-51-890-6709

Other Identifiers

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DW_DWJ1386001

Identifier Type: -

Identifier Source: org_study_id

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