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

Merz Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Neramexane mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712283

MRZ 92579-0628/1

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

64 participants in 4 patient groups, including a placebo group

D

Placebo Comparator group

Description:

healthy volunteers

Treatment:

Drug: Neramexane mesylate

C

Active Comparator group

Description:

healthy volunteers

Treatment:

Drug: Neramexane mesylate

B

Active Comparator group

Description:

healthy volunteers

Treatment:

Drug: Neramexane mesylate

A

Active Comparator group

Description:

healthy volunteers

Treatment:

Drug: Neramexane mesylate