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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650169 |
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 fed 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 Food In Vivo Bioequivalence Study of Clopidogrel Bisulfate Tablets (75 mg; Mylan) to Plavix® Tablets (75 mg; Bristol-Myers Squibb/Sanofi) in Healthy Volunteers |
| Enrollment: | 47 |
| Study Start Date: | December 2004 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | January 2005 (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 fed
|
|
2: Active Comparator
Plavix® Tablets 75 mg
|
Drug: Plavix® Tablets 75 mg
75mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing for each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.
b. 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:
(1) postmenopausal with an absence of menses for at least one (1) year, or (2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or (3) total hysterectomy d. During the course of the study, from study screen until study exit - including the washout period, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
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-0403 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650169 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 |