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Sponsored by: |
Roxane Laboratories |
---|---|
Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00602173 |
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.
Condition | Intervention |
---|---|
Intermittent Claudication |
Drug: Cilostazol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 mg Tablets Under Fasting Conditions |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
CEDRA Clinical Research, LLC | |
Austin, Texas, United States, 78759 |
Principal Investigator: | Daniel V Freeland, DO | CEDRA Clinical Research, LLC |
Responsible Party: | Roxane Labortories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | CILO-03 |
Study First Received: | January 15, 2008 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00602173 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Cilostazol Signs and Symptoms |
Vascular Diseases Intermittent Claudication Arteriosclerosis |
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 Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |