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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT01448330

First received: September 27, 2011

Last updated: December 28, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2011

Last Updated Date

December 28, 2011

Start Date ^ICMJE

July 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cmax [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
AUC [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01448330 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: HCP0911 / clopidogrel, aspirin

combination tablet vs coadministration

Study Arm (s)

Experimental: HCP0911
clopidogrel/aspirin combination tablet

Intervention: Drug: HCP0911 / clopidogrel, aspirin
Active Comparator: clopidorel and aspirin
coadministration of clopidogrel and aspirin

Intervention: Drug: HCP0911 / clopidogrel, aspirin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01448330

Other Study ID Numbers ^ICMJE

HM-CPAS-101

Has Data Monitoring Committee

Responsible Party

Hanmi Pharmaceutical Company Limited

Study Sponsor ^ICMJE

Hanmi Pharmaceutical Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jae-wook Ko, MD

Samsung Medical Center

Information Provided By

Hanmi Pharmaceutical Company Limited

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top