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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Traclear; Drug: HGP1206

Study type: Interventional

Funder types: Industry

Identifiers

NCT01864863

HM-BOTAN-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Test→Reference

Experimental group

Description:

HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets

Treatment:

Drug: HGP1206

Drug: Traclear

Reference→Test

Experimental group

Description:

Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet

Treatment:

Drug: HGP1206

Drug: Traclear