parkinson's disease
Conditions
Interventions
The study will start with a screening At the screening a physical examination
will take place and a few other standard medical assessments will be performed
( Vital Signs). Furthermore a blood and u
Sponsors
Synthon B.V
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability and bioequivalence | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a.p | — |
Countries
Netherlands
Outcome results
None listed