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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCP0911 / clopidogrel, aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448330

HM-CPAS-101

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

HCP0911

Experimental group

Description:

clopidogrel/aspirin combination tablet

Treatment:

Drug: HCP0911 / clopidogrel, aspirin

clopidorel and aspirin

Active Comparator group

Description:

coadministration of clopidogrel and aspirin

Treatment:

Drug: HCP0911 / clopidogrel, aspirin