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

Intermittent Claudication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773630
• Other study ID #: 21-08-101
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: September 8, 2011
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Otsuka Frankfurt Research Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Drug:
• Cilostazol
100 mg Cilostazol

Locations

Country	Name	City	State
Germany	AAIPharma Deutschland GmbH & Co. KG	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Frankfurt Research Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve, maximal concentration (Cmax)		1-2 months	No
Secondary	Time of maximum (tmax), Vss/f, CL/f)		1-2 months	No