NL-OMON36833
Completed
Not Applicable
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 - CT.PAL.mrt.45.12.001
Synthon B.V0 sites52 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- parkinson's disease
- Sponsor
- Synthon B.V
- Enrollment
- 52
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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