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

Hanmi Pharmaceutical Company Limited28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

HGP1206DRUG

One Bosentan 125 mg tablet

TraclearDRUG

Two Bosentan 62.5 mg tablets

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

Time frame: 0-24h

Cmax

Time frame: 0-24h

Secondary Outcomes

Tmax

Time frame: 0~24h

AUCinf

Time frame: 0~24h

t1/2

Time frame: 0~24h

Data from ClinicalTrials.gov

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