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

NCT ID: NCT00773630

Last Updated: 2011-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-03-31

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.

Conditions

Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Intake of Pletal 100 mg tablets dose together with 200 ml water

Group Type: ACTIVE_COMPARATOR

Cilostazol

Intervention Type: DRUG

100 mg Cilostazol

B

Intake of Pletal 100 mg ODT dose without water

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

100 mg Cilostazol

C

Intake of Pletal 100 mg ODT dose together with 200 ml water

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: DRUG

100 mg Cilostazol

D

Intake of Pletal 100 mg ODT dose without water

Group Type: ACTIVE_COMPARATOR

Cilostazol

Intervention Type: DRUG

100 mg Cilostazol

Interventions

Cilostazol

100 mg Cilostazol

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Frankfurt Research Institute GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margarete Mueller, Dr.

Role: PRINCIPAL_INVESTIGATOR

AAIPharma Deutschland GmbH & Co. KG

Locations

AAIPharma Deutschland GmbH & Co. KG

Neu-Ulm, , Germany

Countries

Germany

Other Identifiers

21-08-101

Identifier Type: -

Identifier Source: org_study_id