Driving Simulation to Assess Non-Sedative Effects of Tolperisone

Exclusion Criteria

• •1. Subjects who have any clinically significant unstable medical abnormality, chronic disease or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems.
• •2. Subjects who test positive at screening for hepatitis B surface antigen, hepatitis C antibody or have a history of a positive result.
• •3. Subjects who are known to be seropositive or test positive at Screening for Human immunodeficiency virus (HIV).
• •4. Female subjects who are pregnant or lactating.
• •5. Subjects who have a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
• •6. A history within 2 years of, or current treatment for a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
• •7. A history of difficulty in falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator.
• •8. Subjects who have a history or diagnosis of any of the following conditions:
• •1. Primary or secondary insomnia
• •2. Narcolepsy
• •3. Cataplexy (familial or idiopathic)
• •4. Circadian Rhythm Sleep Disorder
• •5. Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement behavior disorder
• •6. Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome)
• •7. Periodic Limb Movement Disorder
• •8. Restless Legs Syndrome
• •9. Primary Hypersomnia
• •10. Excessive Daytime Sleepiness (EDS)
• •11. Subject has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
• •9. Subjects expected to use any other medication or dietary supplement to promote sleep including over-the-counter sleep medications, during their participation in the study.
• •10. Subjects who have participated in any investigational study within 30 days prior to screening or are currently participating in another clinical trial.
• •11. Subjects who have had a recent history (less than 2 years before entering the study) of drug or alcohol abuse, or current positive urine drug screen. Alcohol abuse is defined as current consumption of more than three alcoholic beverages per day.
• •12. Subjects who have a history of allergic reaction to tolperisone or cyclobenzaprine or any components of these study medications.
• •13. Use of psychoactive prescription or non-prescription medications, psychoactive nutritional supplements or herbal preparations within 2 weeks or 5 half-lives (whichever is longer) of admission to the Clinical Research Unit (CRU) on Day 1.
• •14. Presence of a medical or psychiatric condition which could jeopardize the safety of the subject or validity of study results
• •15. Subjects who consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day. Excessive amount is defined as greater than 6 servings per day (where 1 serving is approximately equivalent to 120 mg of caffeine).
• •16. Subjects who will be working a night shift within 1 week of a visit.
• •17. Subject who have traveled across 1 or more time zones (transmeridian travel) in the last 2 weeks prior to randomization or is expected to travel across 1 or more time zones during the study.
• •18. Current smoker (\>10 cigarettes or eCigarettes, 3 cigars, or 3 pipes per day) and unwilling to refrain from smoking while confined to the CRU for periods of 3 days.
• •19. Subjects who have an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
• •20. Subjects who are a staff member or relative of a staff member.