Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
NCT01388660 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2014-03-26
Summary
This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.
Conditions
Interventions
- DRUG
-
Cloas
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, PO, 2 tablet once daily for Period I \& II Day 1 (crossover manner)
- DRUG
-
Plavix/Astrix
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin), 2 tablets once daily for Period I \& II Day 1 (crossover manner)
Sponsors & Collaborators
-
Ajou University School of Medicine
lead OTHER
Principal Investigators
-
Doo-Yeoun Cho, MD · Ajou University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2014-09-30
- Completion
- 2014-12-31
Countries
- South Korea
Study Locations
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