NCT01657071

Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects

A Randomized, Open-label, Single Dose, 2-treatment, 2-period, 2-way Crossover Study to Assess the Pharmacokinetic Characteristics of YH14659, a Fixed Dose Combination Compared With Coadministration of Separate Constituents Under Fasted Conditions in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare pharmacokinetics after single oral administration of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in healthy male volunteers.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	YH14659	YH14659 capsule by oral
DRUG	clopidogrel & aspirin	clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-08-03
• Last updated: 2012-08-03

Locations

1 site across 1 country: South Korea