NCT01864863

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	HGP1206	One Bosentan 125 mg tablet
DRUG	Traclear	Two Bosentan 62.5 mg tablets

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-05-30
• Last updated: 2016-10-21

Locations

1 site across 1 country: South Korea