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

Hanmi Pharmaceutical Company Limited64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

HCP0911 / clopidogrel, aspirinDRUG

combination tablet vs coadministration

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax

Time frame: 0-24 hrs

AUC

Time frame: 0-24 hrs

Data from ClinicalTrials.gov

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