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

September 27, 2011
December 28, 2011
July 2011
September 2011   (final data collection date for primary outcome measure)
  • Cmax [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
  • AUC [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01448330 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration
  • 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
Jung JA, Kim TE, Kim JR, Kim MJ, Huh W, Park KM, Lee SY, Ko JW. The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, single-dose crossover study. Clin Ther. 2013 Jul;35(7):985-94. doi: 10.1016/j.clinthera.2013.05.015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01448330
HM-CPAS-101
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Jae-wook Ko, MD Samsung Medical Center
Hanmi Pharmaceutical Company Limited
September 2011

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