|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01652313 |
|
Date of registration:
|
23/07/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
|
|
Scientific 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 |
|
Date of first enrolment:
|
May 2012 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01652313 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Email contact via H. Lundbeck A/S |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
LundbeckClinicalTrials@lundbeck.com |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: Rasagiline
|
|
Primary Outcome(s)
|
|
Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
[Time Frame: 7 days]
|
|
PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)
[Time Frame: 7 days]
|
|
Secondary Outcome(s)
|
|
Number of patients with adverse events as a measure of safety and tolerability
[Time Frame: 7 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|