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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier:
NCT00773630
First received: October 15, 2008
Last updated: September 8, 2011
Last verified: March 2009
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • Area under the curve, maximal concentration (Cmax) [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of maximum (tmax), Vss/f, CL/f) [ Time Frame: 1-2 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773630

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

No publications provided

Responsible Party: Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier: NCT00773630     History of Changes
Other Study ID Numbers: 21-08-101
Study First Received: October 15, 2008
Last Updated: September 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 21, 2014