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COMPLETED
NCT06382662
PHASE4

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

Sponsor: Primus Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-04-29

Completion Date

2025-03-06

Last Updated

2026-09-11

Healthy Volunteers

Yes

Interventions

DRUG

metaxalone m640 mg

A single dose of micronize metaxalone 640 mg

DRUG

tizanidine 8mg

A single dose of tizanidine 8 mg

Locations (1)

Sun Valley Arthritis Center

Peoria, Arizona, United States