Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
NCT00712283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2009-12-07
Summary
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo
Conditions
- Healthy
Interventions
- DRUG
-
Neramexane mesylate
tablets Group A: duration: 12,5 mg for 7 days and 25 mg for 8 days Group B: duration: 25 mg for 7 days and 50 mg for 8 days Group C: duration: 50 mg for 7 days and 75 mg for 8 days Group D: duration: placebo for 15 days
Sponsors & Collaborators
-
Merz Pharmaceuticals GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-06-30
Countries
- Germany
Study Locations
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