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Sponsored by: |
Mutual Pharmaceutical Company, Inc. |
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Information provided by: | Mutual Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00684762 |
The objective of this study was to compare the plasma levels of cilostazol produced after administration of the test formulation with those produced after administration of the marketed reference product, under fasting conditions
Condition | Intervention | Phase |
---|---|---|
Therapeutic Equivalency |
Drug: Cilostazol |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Comparative Bioavailability Study of Cilostazol Tablets, 100mg Under Fasting Conditions |
Enrollment: | 32 |
Study Start Date: | March 2004 |
Study Completion Date: | March 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
one test product tablet was administered at 0 hour with 240 mL of room temperature water
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Drug: Cilostazol
Tablet, 100 mg
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B: Active Comparator
one tablet of the reference listed drug, Pletal, was administered at 0 hour with 240 mL of room temperature water
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Drug: Cilostazol
Tablet, 100 mg
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D ) |
Study ID Numbers: | 11788 |
Study First Received: | May 24, 2008 |
Last Updated: | May 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00684762 |
Health Authority: | United States: Institutional Review Board |
Cilostazol |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents 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 |