A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning

Phase 2

Completed

• Conditions: gezonde proefpersonen; slaperigheid bij rijden na inname medicatie; the possible sedative effects of the medication

• Registration Number: NL-OMON42658
• Lead Sponsor: Sun Pharma Advanced Research Company (SPARC) limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

-The potential participant has given informed and written consent and is able to comply with all study assessments scheduled in the protocol
-Healthy males or females aged 21 to 45 years (both inclusive) with body mass index between 18 and 30 kg/m2 and having normal vision
-Possession of a valid Netherlands driver*s license * 3 years with a reported average annual mileage * 5,000 km during the last 3 years
-Any female surgically sterile (bilateral tubal ligation at least 6 months prior, bilateral oophorectomy, or hysterectomy performed) or any female of child bearing potential should be willing to practice an acceptable method of birth control following screening to completion of study of the study. The acceptable contraceptive methods are condoms, diaphragm, intrauterine device (IUD), same sex partner or partner with vasectomy, (note: hormonal contraception is not permitted as it affects tizanidine pharmacokinetics)
-Potential subjects considered healthy based on medical evaluation, electrocardiogram and laboratory values at screening, all lab values are within normal limits or any value out of normal limits considered by the Investigator to be of no clinical significance. lab tests:(Hematology: hemoglobin [Hb] and leukocytes; Biochemistry: C-reactive protein [CRP], creatinine, gamma-glutamyl transpeptidase [Gamma-GT], aspartate aminotransferase [ASAT], alanine aminotransferase [ALAT], bilirubin

Exclusion Criteria

1. History of allergies or hypersensitivity or intolerance to tizanidine or diphenhydramine
2. History or presence of clinically significant or uncontrolled cardiovascular, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, musculoskeletal or sleep disorder
3. History of surgery within 4 weeks of screening
4. Clinical lab results suggestive of hepatic impairment (ALT or AST or bilirubin > 2 times of ULN) or renal impairment (creatinine > 2 mg/dL)
5. Clinically significant history of alcohol intake (> 21 drinks per week).
6. History of drug abuse with drugs used for recreational purpose within one year of the screening visit
7. Use of any drug known to induce or inhibit hepatic drug metabolism (specifically CPY1A2 inhibitors, fluoroquinolones, zileuton, antiarrythmics, anti-histamines, ticlopidine, anti-virals, oral contraceptives, anti-depressants and any drugs known to cause change in neurological function) within 14 days of screening to end of study
8. Signs or symptoms of narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction
9. History of participation in an investigational drug study within the past 30 days
10. History of excessive caffeine consumption (> 5 cups/day) or smoking (*10 cigarettes per day) during the last six months prior to screening
11. At admission for each period: evidence of pregnancy (urine pregnancy test positive on urine drug screen for women), or demonstrable blood-alcohol concentration (alcohol breath test)
12. Pregnant or lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Driving simulator measurement at baseline and at four scheduled time points<br /><br>post dose of standard deviation lateral position (SDLP) in centimeters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Psychomotor and cognitive function- at baseline and at four scheduled time<br /><br>points post dose. Reaction time to:<br /><br>o Visual stimulus on psychomotor vigilance task (PVT) in milliseconds<br /><br>o Visual stimulus on vigilance and tracking (VigTrack) task in milliseconds<br /><br>o Light emitting diode (LED) in milliseconds<br /><br>* Driving simulator measurement at baseline and at four scheduled time points<br /><br>post dose of:<br /><br>o Lateral position in centimeters<br /><br>o Standard deviation of speed (SDSP) in miles per hour<br /><br>o Distance headway (DHW) in kilometers<br /><br>o Time-to-collision (TTC) in seconds<br /><br>o Time headway (THW) in seconds<br /><br>* Subjective assessment of sleepiness:<br /><br>A subjective rating with scores 1 to 9 for alertness using Karolinska<br /><br>Sleepiness Scale (KSS)</p><br>