Clinical trial NCT00773630: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intermittent Claudication
Lead sponsor: Otsuka Frankfurt Research Institute GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Area under the curve, maximal concentration (Cmax)
timeFrame: 1-2 months
Secondary outcomes:
measure: Time of maximum (tmax), Vss/f, CL/f)
timeFrame: 1-2 months
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: AAIPharma Deutschland GmbH & Co. KG
Study officials:
affiliation: AAIPharma Deutschland GmbH & Co. KG
name: Margarete Mueller, Dr.
role: PRINCIPAL_INVESTIGATOR
References: