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Sponsored by: |
Otsuka Frankfurt Research Institute GmbH |
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Information provided by: | Otsuka Frankfurt Research Institute GmbH |
ClinicalTrials.gov Identifier: | NCT00773630 |
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.
Condition | Intervention | Phase |
---|---|---|
Intermittent Claudication |
Drug: Cilostazol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Estimated Enrollment: | 44 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Intake of Pletal 100 mg tablets dose together with 200 ml water
|
Drug: Cilostazol
100 mg Cilostazol
|
B: Experimental
Intake of Pletal 100 mg ODT dose without water
|
Drug: Cilostazol
100 mg Cilostazol
|
C: Experimental
Intake of Pletal 100 mg ODT dose together with 200 ml water
|
Drug: Cilostazol
100 mg Cilostazol
|
D: Active Comparator
Intake of Pletal 100 mg ODT dose without water
|
Drug: Cilostazol
100 mg Cilostazol
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
AAIPharma Deutschland GmbH & Co. KG | |
Neu-Ulm, Germany, 89231 |
Principal Investigator: | Margarete Mueller, Dr. | AAIPharma Deutschland GmbH & Co. KG |
Responsible Party: | Otsuka Frankfurt Research Institute GmbH ( Otsuka Frankfurt Research Institute GmbH ) |
Study ID Numbers: | 21-08-101, No |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773630 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Arterial Occlusive Diseases Cilostazol Signs and Symptoms Malnutrition Infectious Mononucleosis |
Vascular Diseases Intermittent Claudication Healthy Arteriosclerosis |
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 Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |