title: Assessment of doxylamine influence on mixed function oxidase activity upon multiple dose oral administration to normal volunteers.
abstract: The primary purpose of this study was to assess the influence of doxylamine and phenobarbital on antipyrine/metabolites pharmacokinetics and 6 beta-hydroxycortisol urinary excretion. This study was conducted in 48 healthy male human volunteers (16 per treatment group) using a parallel study design. Treatment groups consisted of 12.5 mg of doxylamine succinate, placebo, or 30 mg of phenobarbital administered orally every 6 h for 17 days. Results indicate that no statistically significant differences were observed between the doxylamine and placebo groups that are indicative of enzyme induction. For the phenobarbital group, a significant increase for antipyrine total (36 versus 45 mL/h/kg) and nonrenal (35 versus 44 mL/h/kg) clearances and 6 beta-hydroxycortisol excretion (338 versus 529 micrograms) and a significant decrease in the terminal exponential half-life (11 versus 9 h) of antipyrine were observed.
authors.affiliation: Procter & Gamble Pharmaceuticals, Cincinnati, OH 45242, USA.
authors.forename: G A
authors.initials: GA
authors.lastname: Thompson
authors.forename: J V
authors.initials: JV
authors.lastname: St Peter
authors.forename: M A
authors.initials: MA
authors.lastname: Heise
authors.forename: Z D
authors.initials: ZD
authors.lastname: Horowitz
authors.forename: G C
authors.initials: GC
authors.lastname: Salyers
authors.forename: T T
authors.initials: TT
authors.lastname: Charles
authors.forename: C
authors.initials: C
authors.lastname: Brezovic
authors.forename: D A
authors.initials: DA
authors.lastname: Russell
authors.forename: J A
authors.initials: JA
authors.lastname: Skare
authors.forename: J H
authors.initials: JH
authors.lastname: Powell
mesh_terms: D000284:Administration, Oral; D000328:Adult; D004319:Doxylamine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology*; D006801:Humans; D008297:Male; D006899:Mixed Function Oxygenases / Q000187:drug effects* / Q000378:metabolism; D010919:Placebos; D012016:Reference Values
chemical_list: D010919:Placebos; D004319:Doxylamine; D006899:Mixed Function Oxygenases