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The primary objective of this trial is to test whether Pletal ODT administered without water can be considered bioequivalent to Pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables.
The secondary objective is to assess the effect of water and the effect of food on the administration of Pletal ODT based on standard pharmacokinetic variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Intake of Pletal 100 mg tablets dose together with 200 ml water |
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| B | Experimental | Intake of Pletal 100 mg ODT dose without water |
|
| C | Experimental | Intake of Pletal 100 mg ODT dose together with 200 ml water |
|
| D | Active Comparator | Intake of Pletal 100 mg ODT dose without water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | 100 mg Cilostazol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve, maximal concentration (Cmax) | 1-2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum (tmax), Vss/f, CL/f) | 1-2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margarete Mueller, Dr. | AAIPharma Deutschland GmbH & Co. KG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AAIPharma Deutschland GmbH & Co. KG | Neu-Ulm | 89231 | Germany |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, 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 |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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