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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648388 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Cilostazol Tablets 100 mg Drug: Pletal® Tablets 100 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 Cilostazol Tablets (100 mg; Mylan) and Pletal® Tablets(100 mg; Otsuka) in Healthy Volunteers |
| Enrollment: | 44 |
| Study Start Date: | March 2004 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Cilostazol Tablets 100 mg
|
Drug: Cilostazol Tablets 100 mg
100mg, single dose fasting
|
|
2: Active Comparator
Pletal® Tablets 100 mg
|
Drug: Pletal® Tablets 100 mg
100 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 of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
a. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
d. Abnormal and clinically relevant ECG tracing.
Contacts and Locations| United States, Missouri | |
| Gateway Medical Research, Inc. | |
| St. Charles, Missouri, United States, 63301 | |
| Principal Investigator: | Walter A Parham, M.D. | Cetero Research |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | CILO-0395 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648388 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cilostazol Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Protective Agents |
Neuroprotective Agents Pharmacologic Actions Fibrin Modulating Agents Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |