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

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

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

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