Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers

Study Overview
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Brief Summary
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Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo

Official Title
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A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Group Design Study to Investigate the Effect of 12,5 mg, 25 mg, 50 mg and 75 mg Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Neramexane mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: D<br>healthy volunteers | Drug: Neramexane mesylate<br>* 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<br>|
| Active Comparator: C<br>healthy volunteers | Drug: Neramexane mesylate<br>* 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<br>|
| Active Comparator: B<br>healthy volunteers | Drug: Neramexane mesylate<br>* 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<br>|
| Active Comparator: A<br>healthy volunteers | Drug: Neramexane mesylate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitness to drive |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric test and motor control tests |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fitness to drive, operate machines, To determine the fitness to drive and operate machines.