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A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00773630
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : September 9, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Intermittent Claudication Drug: Cilostazol Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Intake of Pletal 100 mg tablets dose together with 200 ml water
Drug: Cilostazol
100 mg Cilostazol
Experimental: B
Intake of Pletal 100 mg ODT dose without water
Drug: Cilostazol
100 mg Cilostazol
Experimental: C
Intake of Pletal 100 mg ODT dose together with 200 ml water
Drug: Cilostazol
100 mg Cilostazol
Active Comparator: D
Intake of Pletal 100 mg ODT dose without water
Drug: Cilostazol
100 mg Cilostazol

Outcome Measures

Primary Outcome Measures :
  1. Area under the curve, maximal concentration (Cmax) [ Time Frame: 1-2 months ]

Secondary Outcome Measures :
  1. Time of maximum (tmax), Vss/f, CL/f) [ Time Frame: 1-2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. healthy male and female subjects of Caucasian race
  2. able to read, to write and to fully understand German language
  3. having given voluntary written informed consent before first invasive screening examination procedure
  4. aged 18 to 45 years, inclusive
  5. BMI of 18 - 28 kg/m2
  6. good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)

Exclusion Criteria:

  1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
  2. known hypersensitivity to one of the IMP substances
  3. severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
  4. clinically relevant renal disorders (albuminuria, chronic infections)
  5. clinically relevant hepatic disorders
  6. clinically relevant respiratory disorders
  7. clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (TdP) (e.g. heart failure, hypokalemia, congenital long QT-syndrome)
  8. diabetes mellitus and thyroid dysfunction or other endocrine disorders
  9. malignancy
  10. substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
  11. neurologic or psychiatric illness
  12. known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773630

AAIPharma Deutschland GmbH & Co. KG
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Principal Investigator: Margarete Mueller, Dr. AAIPharma Deutschland GmbH & Co. KG
More Information

Responsible Party: Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier: NCT00773630     History of Changes
Other Study ID Numbers: 21-08-101
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: March 2009

Additional relevant MeSH terms:
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors