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Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

NCT06348303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-07

No results posted yet for this study

Summary

Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

Conditions

  • Healthy Participants

Interventions

DRUG

Metaxalone m640 mg oral tablet

Metaxalone partially micronized 640 mg tablet

DRUG

Metaxalone 800 mg oral tablet

Metaxalone non-micronized 800 mg oral tablet

Sponsors & Collaborators

  • ClinOhio Research Services, LLC

    collaborator INDUSTRY

  • Primus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • J Lukban, DO · Primus Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2024-09-05
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06348303 on ClinicalTrials.gov