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

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01864863

Enrollment

Registered

2013-05-30

Start date

2013-04-30

Completion date

2013-05-31

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

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

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.

Interventions

DRUGHGP1206

One Bosentan 125 mg tablet

DRUGTraclear

Two Bosentan 62.5 mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUClast	0-24h
Cmax	0-24h

Secondary

Measure	Time frame
Tmax	0~24h
AUCinf	0~24h
t1/2	0~24h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026