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NCT01864863 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01864863
Other study ID # HM-BOTAN-101
Secondary ID
Status Completed
Phase Phase 1
First received May 20, 2013
Last updated October 19, 2016
Start date April 2013
Est. completion date May 2013

Study information
Verified date October 2016
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HGP1206
One Bosentan 125 mg tablet
• Traclear
Two Bosentan 62.5 mg tablets

Locations
Country Name City State
Korea, Republic of Samsung medical center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUClast 0-24h No
Primary Cmax 0-24h No
Secondary Tmax 0~24h No
Secondary AUCinf 0~24h No
Secondary t1/2 0~24h No
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