Parkinson's Disease
Conditions
Brief summary
The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.
Interventions
DRUGRasagiline
1 mg/day, tablets for 7 days, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is a Chinese man or woman * The subject is, in the opinion of the investigator, generally healthy * If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
Exclusion criteria
* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI) | 7 days |
| PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI) | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | 7 days |
Countries
China
Outcome results
None listed