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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648947 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Clopidogrel Bisulfate Tablets 75 mg Drug: Plavix® Tablets 75 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Clopidogrel Bisulfate Tablets (75 mg; Mylan) to Plavix® Tablets (75 mg; Bristol-Myers Squibb/Sanofi) in Healthy Volunteers |
| Enrollment: | 46 |
| Study Start Date: | December 2004 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Clopidogrel Bisulfate Tablets 75 mg
|
Drug: Clopidogrel Bisulfate Tablets 75 mg
75mg, single dose fasting
|
|
2: Active Comparator
Plavix® Tablets 75 mg
|
Drug: Plavix® Tablets 75 mg
75mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | CLOP-0402 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648947 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fibrin Modulating Agents Ticlopidine Molecular Mechanisms of Pharmacological Action Therapeutic Uses Clopidogrel |
Hematologic Agents Fibrinolytic Agents Platelet Aggregation Inhibitors Cardiovascular Agents Pharmacologic Actions |