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.

First Received on October 15, 2008. Last Updated on September 8, 2011 History of Changes

Sponsor:	Otsuka Frankfurt Research Institute GmbH
Information provided by (Responsible Party):	Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov Identifier:	NCT00773630

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 I

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:

Drug Information available for: Cilostazol

U.S. FDA Resources

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:

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

Exclusion Criteria:

clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
known hypersensitivity to one of the IMP substances
severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
clinically relevant renal disorders (albuminuria, chronic infections)
clinically relevant hepatic disorders
clinically relevant respiratory disorders
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)
diabetes mellitus and thyroid dysfunction or other endocrine disorders
malignancy
substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
neurologic or psychiatric illness
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

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012