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

Phase 1

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: HGP1206; Drug: Traclear

• Registration Number: NCT01864863
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-05-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test→Reference	HGP1206	HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
Test→Reference	Traclear	HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
Reference→Test	HGP1206	Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet
Reference→Test	Traclear	Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet

Primary Outcome Measures

Name	Time	Method
Cmax	0-24h
AUClast	0-24h

Secondary Outcome Measures

Name	Time	Method
Tmax	0~24h
AUCinf	0~24h
t1/2	0~24h

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of