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

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Claudication
• Intervention / Treatment: Drug: Cilostazol

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neu-Ulm, Germany, 89231
    • AAIPharma Deutschland gmbH & Co. KG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve, maximal concentration (Cmax)	1-2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of maximum (tmax), Vss/f, CL/f)	1-2 months

Collaborators and Investigators

• Sponsor: Otsuka Frankfurt Research Institute GmbH
• Investigators: Principal Investigator: Margarete Mueller, Dr., AAIPharma Deutschland gmbH & Co. KG

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 15, 2008
• First Posted (Estimate): October 16, 2008

Study Record Updates

• Last Update Posted (Estimate): September 9, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: 21-08-101