Status:
COMPLETED
Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo
Eligibility Criteria
Inclusion
- healthy volunteers, female and male
- age 21 - 50
- BMI 18 - 30 kg/m2
- experienced drivers with a valid driver's license and at least 3 years of driving practice
Exclusion
- any clinically relevant finding on physical examination affecting the study objectives
- clinically relevant abnormalities in the ECG laboratory values
- history or present evidence of clinically relevant metabolic, renal, hepatic, pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding diagnosis of malignancy
- females who are pregnant or breastfeeding
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00712283
Start Date
July 1 2008
End Date
June 1 2009
Last Update
December 7 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Merz Pharmaceuticals
Frankfurt am Main, Germany, 60318