Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers

NCT ID: NCT03016520

Last Updated: 2017-02-08

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 in healthy male volunteers.

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 drug

DWJ1392

Group Type EXPERIMENTAL

DWJ1392

Intervention Type DRUG

Reference drug

DWC20164

Group Type EXPERIMENTAL

DWC20164

Intervention Type DRUG

Interventions

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DWJ1392

Intervention Type DRUG

DWC20164

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No clinically significant findings
* Age 19-50 years at screening

Exclusion Criteria

* Who has allergy to investigational product
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 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

Locations

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Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Han Seunghoon

Role: primary

82-2-2258-7877

Other Identifiers

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DW_DWJ1392001

Identifier Type: -

Identifier Source: org_study_id

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