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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: HCP0911 / clopidogrel, aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

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

Enrollment: 64
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCP0911
clopidogrel/aspirin combination tablet
Drug: HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration
Active Comparator: clopidorel and aspirin
coadministration of clopidogrel and aspirin
Drug: HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448330

Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Jae-wook Ko, MD Samsung Medical Center
  More Information

No publications provided by Hanmi Pharmaceutical Company Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01448330     History of Changes
Other Study ID Numbers: HM-CPAS-101
Study First Received: September 27, 2011
Last Updated: December 28, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
clopidogrel
aspinin
combination

Additional relevant MeSH terms:
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 17, 2014