Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
- Registration Number
- NCT01652313
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rasagiline Rasagiline -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of patients with adverse events as a measure of safety and tolerability 7 days
Trial Locations
- Locations (1)
CN001
🇨🇳Beijing, China