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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung medical center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP0911 / clopidogrel, aspirin

Drug

combination tablet vs coadministration

Primary outcomes

Cmax

Time frame: 0-24 hrs
AUC

Time frame: 0-24 hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Sequence-randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetics and Safety After Oral Administration of Clopidogrel and Aspirin in Free Combination and Fixed-dose Combination as HCP0911 in Healthy Male Volunteers

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Oct 7, 2011
Registry last updated: Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed