Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

Resource links provided by NLM:

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline Drug: Rasagiline
1 mg/day, tablets for 7 days, orally
Other Name: Lu 00-773; Azilect®


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts 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 exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01652313

Beijing, China
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S Identifier: NCT01652313     History of Changes
Other Study ID Numbers: 13496A 
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016