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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01448330

Enrollment

Registered

2011-10-07

Start date

2011-07-31

Completion date

2011-09-30

Last updated

2011-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

clopidogrel, aspinin, combination

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.

Interventions

DRUGHCP0911 / clopidogrel, aspirin

combination tablet vs coadministration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax	0-24 hrs
AUC	0-24 hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026