Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
Tracking Information | |||||
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First Received Date ICMJE | June 14, 2012 | ||||
Last Updated Date | June 14, 2012 | ||||
Start Date ICMJE | August 2008 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Area under curve(AUC) [ Time Frame: at pre-dose 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions | ||||
Official Title ICMJE | An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Tablets Under Fasting Conditions | ||||
Brief Summary | To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fasting conditions and to assess the bioequivalence. |
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Detailed Description | An open label, balanced, randomized, two treatment, two sequence, two period, single-dose, crossover oral bioequivalence study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Tablets of Bristol-Myers Squibb/Sanofi pharmaceuticals partnership Bridgewater, NJ 0880750086441, USA, in healthy, adult, human male subjects under fasting conditions. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Fasting | ||||
Intervention ICMJE | Drug: Clopidogrel
Clopidogrel Tablets 300 mg
Other Name: Plavix |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 68 | ||||
Completion Date | September 2008 | ||||
Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: In case the blood loss was less than or equal to 200 mL; subject was enrolled 60 days after blood donation.
Note: If subject had participated in a study in which blood loss was less than or equal to 200 mL, subject was dosed 60 days after the last sample of previous study.
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Gender | Male | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | India | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01621750 | ||||
Other Study ID Numbers ICMJE | 300-08 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Dr. Reddy's Laboratories Limited | ||||
Study Sponsor ICMJE | Dr. Reddy's Laboratories Limited | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Dr. Reddy's Laboratories Limited | ||||
Verification Date | August 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |