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| Sponsor: | Mutual Pharmaceutical Company, Inc. |
|---|---|
| Information provided by: | Mutual Pharmaceutical Company, Inc. |
| ClinicalTrials.gov Identifier: | NCT00685802 |
Purpose
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Therapeutic Equivalency, Healthy |
Drug: Cilostazol 50 mg Tablets Drug: Cilostazol (Pletal®) 50 mg Tablets |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-availability Study |
| Official Title: | A Comparative Bioavailability Study of Cilostazol Tablets, 50mg, Under Fasting Conditions |
| Enrollment: | 32 |
| Study Start Date: | June 2004 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cilostazol 50 mg Tablets: Experimental
A single dose of cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours.
|
Drug: Cilostazol 50 mg Tablets
Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours
|
|
Cilostazol (Pletal® ) 50 mg Tablets: Experimental
A single dose of Cilostazol (Pletal® tablets, 2 x 50 mg ) administered after an overnight fast of at least 10 hours.
|
Drug: Cilostazol (Pletal®) 50 mg Tablets
Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.
|
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (2 x 50 mg tablets), or a single oral dose of the reference formulation, Pletal® (2 x 50 mg tablets). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Mutual Pharmaceutical Company, Inc. ( Kristin Arnold, Vice President R&D ) |
| Study ID Numbers: | 11801 |
| Study First Received: | May 24, 2008 |
| Results First Received: | November 18, 2009 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00685802 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 |