A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HCP0911 / clopidogrel, aspirin

• Registration Number: NCT01448330
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-07
• Last Update Submitted: 2011-12-28
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Age between 20 and 55
• Signed informed consent

Exclusion Criteria

• Has a history of hypersensitivity to IP ingredients
• Hypotension or hypertension
• Has a history of acute infection within 14days of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCP0911	HCP0911 / clopidogrel, aspirin	clopidogrel/aspirin combination tablet
clopidorel and aspirin	HCP0911 / clopidogrel, aspirin	coadministration of clopidogrel and aspirin

Primary Outcome Measures

Name	Time	Method
Cmax	0-24 hrs
AUC	0-24 hrs

Trial Locations

Locations (1)

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