An open label, crossover study to investigate the safety and tolerability of Sifrol® (pramipexole) (Boehringer Ingelheim) prolonged release tablets in order to establish the maximum tolerable dose and to assess bioequivalence of Pramipexole prolonged release tablets (Synthon B.V.) compared to Sifrol® prolonged release tablets (Boehringer Ingelheim) in healthy subjects in steady-state conditions
- Conditions
- parkinson's disease10042258
- Registration Number
- NL-OMON36833
- Lead Sponsor
- Synthon B.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
1. Healthy, non-smoking, non-vegetarian, Caucasian male volunteers, 18 - 55 years of age, inclusive.;2. Body Mass Index (BMI) that is within 18.5-30.0 kg/m², inclusive.;3. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by Principal Investigator/Sub-Investigator.;4. Supine blood pressure between 90-150 mm Hg, inclusive, systolic and 50-90 mm Hg, inclusive, diastolic and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the Principal Investigator/Sub-Investigator. ;Refer to protocol for a complete list of the inclusion criteria.
1. Known history or presence of any medical conditon determined as clinically significant by Principal Investigator/Sub-Investigator.;2. Out of range creatinine clearance in plasma according to Cockroft and Gault.;3. Known history or presence of drug or alcohol abuse, any relevant history of sleep disorder, food allergies ;Refer to protocol for a complete list of the inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>safety, tolerability and bioequivalence</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.p</p><br>