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The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation 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 |
|---|---|---|---|
| Treatment RTRT (R: Cilostazol, T: PMR) | Other | Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment RTRT |
|
| Treatment TRTR (T: PMR, R: Cilostazol) | Other | Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment TRTR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol Tablet 100 mg | Drug | Two oral doses (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 one (1) month prior to screening.
Use of tobacco or nicotine products within six (6) months of screening.
Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
On any investigational drug(s) or therapeutic device(s) within thirty (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 one (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); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening.
Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at any time during the study, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19).
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 the study drug(s).
Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Kayce Morton | Bio-Kinetic Clinical Applications, LLC | Principal Investigator |
| 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 Tablet 135 mg | Drug | Single oral dose (total daily dose of 270 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 |