Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
NCT ID: NCT00712283
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2008-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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D
healthy volunteers
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
C
healthy volunteers
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
B
healthy volunteers
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
A
healthy volunteers
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
50 Years
ALL
Yes
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Merz Pharmaceuticals GmbH
Locations
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Merz Pharmaceuticals
Frankfurt am Main, , Germany
Countries
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Other Identifiers
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MRZ 92579-0628/1
Identifier Type: -
Identifier Source: org_study_id
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