A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin
NCT ID: NCT01448330
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2011-07-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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HCP0911
clopidogrel/aspirin combination tablet
HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration
clopidorel and aspirin
coadministration of clopidogrel and aspirin
HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration
Interventions
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HCP0911 / clopidogrel, aspirin
combination tablet vs coadministration
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Hypotension or hypertension
* Has a history of acute infection within 14days of screening
20 Years
55 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jae-wook Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung medical center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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HM-CPAS-101
Identifier Type: -
Identifier Source: org_study_id