Phase
Condition
N/ATreatment
Metaxalone m640 mg oral tablet
Metaxalone 800 mg oral tablet
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Weigh at least 120 pounds at Screening
Medically healthy with no clinically significant medical co-morbidities impactendpoints
Exclusion
Exclusion Criteria:
Current use of any medications known to affect sleep-wake cycle.
Known sleep disorder.
Current use of cimetidine.
Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptakeinhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5-hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect theserotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
Positive urine test for amphetamines, barbiturates, cocaine, opiates,benzodiazepines, or cannabinoids.
Participants taking skeletal muscle relaxants or sedative hypnotics.
Participants with gastrointestinal disease affecting absorption.
Participants with severe hepatic or renal impairment.
Study Design
Study Description
Connect with a study center
ClinOhio Research Institute
Columbus, Ohio 43213
United StatesActive - Recruiting
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