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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00773630

Enrollment

Registered

2008-10-16

Start date

2008-12-31

Completion date

2009-03-31

Last updated

2011-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

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.

Interventions

DRUGCilostazol

100 mg Cilostazol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026