To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

NCT ID: NCT01864863

Last Updated: 2016-10-21

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.

Detailed Description

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An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.

Conditions

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Pulmonary Arterial Hypertension

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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Test→Reference

HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets

Group Type EXPERIMENTAL

HGP1206

Intervention Type DRUG

One Bosentan 125 mg tablet

Traclear

Intervention Type DRUG

Two Bosentan 62.5 mg tablets

Reference→Test

Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet

Group Type EXPERIMENTAL

HGP1206

Intervention Type DRUG

One Bosentan 125 mg tablet

Traclear

Intervention Type DRUG

Two Bosentan 62.5 mg tablets

Interventions

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HGP1206

One Bosentan 125 mg tablet

Intervention Type DRUG

Traclear

Two Bosentan 62.5 mg tablets

Intervention Type DRUG

Other Intervention Names

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Bosentan 125 mg Traclear 62.5 mg

Eligibility Criteria

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Inclusion Criteria

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria

* Has a history of Primary pulmonary hypertension to investigational product ingredients
* Hypotension or hypertension
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wooseong Huh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-BOTAN-101

Identifier Type: -

Identifier Source: org_study_id

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