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

NCT06382662 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

metaxalone m640

A single dose of micronize metaxalone 640 mg

DRUG

tizanidine

A single dose of tizanidine 8 mg

Sponsors & Collaborators

  • Sun Valley Arthritis Center

    collaborator UNKNOWN

  • Primus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • J C Lukban, DO · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-12-30
Completion
2025-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382662 on ClinicalTrials.gov