Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Description

Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.

Conditions

Cognitive Impairment

Study Overview

Study Details

Study overview

Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.

Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study

Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Condition
Cognitive Impairment
Intervention / Treatment

-

Contacts and Locations

Peoria

Sun Valley Arthritis Center, Peoria, Arizona, United States, 85381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * equal to or greater than 20 years old
  • * weight at least 120 pounds
  • * medically healthy
  • * able to eat a high fat meal
  • * medications known to affect sleep-wake cycle
  • * current use of cimetidine
  • * current use of certain anti-depressants
  • * current us of certain antibiotics
  • * positive urine drug test for mind altering medications

Ages Eligible for Study

20 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Primus Pharmaceuticals,

J C Lukban, DO, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

2025-04-15