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The study is designed to evaluate the bioequivalency between the test formulations of extended-release tablet of cilostazol (PMR) administered once-daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol 100 mg | Active Comparator |
| |
| PMR 150 mg | Experimental |
| |
| PMR 200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol 100 mg | Drug | One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve, from time zero to last measureable time point (AUC (0-t)) | 0-72 hours after morning dose | |
| AUC from time zero to infinity (AUC (0-∞)) | 0-72 hours after morning dose |
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Inclusion Criteria:
Exclusion Criteria:
History of bleeding tendency.
Use of anticoagulant agent(s) within 1 month prior to screening.
Use of tobacco or nicotine products within 6 months of screening.
Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization.
On any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within 1 year prior to screening.
Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Pregnant or breast feeding.
Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
Known or suspected hypersensitivity to any ingredient of study drug(s).
Donated blood or lost more than 150 mL of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications, LLC | Springfield | Missouri | 65802 | United States |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| PMR 150 mg | Drug | Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg) |
|
| PMR 200 mg | Drug | Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg) |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |