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
Information source: Otsuka Frankfurt Research Institute GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intermittent Claudication
Intervention: Cilostazol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Otsuka Frankfurt Research Institute GmbH Official(s) and/or principal investigator(s): Margarete Mueller, Dr., Principal Investigator, Affiliation: AAIPharma Deutschland GmbH & Co. KG
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the curve, maximal concentration (Cmax)
Secondary outcome: Time of maximum (tmax), Vss/f, CL/f)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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)
Locations and Contacts
AAIPharma Deutschland GmbH & Co. KG, Neu-Ulm 89231, Germany
Additional Information
Starting date: December 2008
Last updated: September 8, 2011
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