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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: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
|---|---|
|
Experimental: 1
Cilostazol Tablets 100 mg
|
Drug: Cilostazol Tablets 100 mg
100mg, single dose fasting
|
|
Active Comparator: 2
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, San Antonio |
More Information
| Responsible Party: | Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00648388 History of Changes |
| Other Study ID Numbers: | CILO-0395 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents |
Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |