Status:
COMPLETED
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
Lead Sponsor:
Otsuka Frankfurt Research Institute GmbH
Conditions:
Intermittent Claudication
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 administere...
Eligibility Criteria
Inclusion
- healthy male and female subjects of Caucasian race
- able to read, to write and to fully understand German language
- having given voluntary written informed consent before first invasive screening examination procedure
- aged 18 to 45 years, inclusive
- BMI of 18 - 28 kg/m2
- good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG, serum/urine biochemistry and hematology)
Exclusion
- clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity
- known hypersensitivity to one of the IMP substances
- severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy)
- clinically relevant renal disorders (albuminuria, chronic infections)
- clinically relevant hepatic disorders
- clinically relevant respiratory disorders
- 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)
- diabetes mellitus and thyroid dysfunction or other endocrine disorders
- malignancy
- substance abuse or addiction (alcohol, illicit drugs) in the past 3 years
- neurologic or psychiatric illness
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00773630
Start Date
December 1 2008
End Date
March 1 2009
Last Update
September 9 2011
Active Locations (1)
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1
AAIPharma Deutschland GmbH & Co. KG
Neu-Ulm, Germany, 89231