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About
This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.
Full description
Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule.
Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.
Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
32 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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