Status:
COMPLETED
To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male
- Age between 20 and 55
- Signed informed consent
Exclusion
- Has a history of Primary pulmonary hypertension to investigational product ingredients
- Hypotension or hypertension
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01864863
Start Date
April 1 2013
End Date
May 1 2013
Last Update
October 21 2016
Active Locations (1)
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1
Samsung medical center
Seoul, South Korea