PMID: 16625988Apr 22, 2006Paper

Effect of food intake on the bioavailability of almotriptan, an antimigraine compound, in healthy volunteers: an open, randomized, crossover, single-dose clinical trial

International Journal of Clinical Pharmacology and Therapeutics
J M JansatJ Costa

Abstract

This open, randomized, crossover, single-dose clinical trial evaluated the possible pharmacokinetic interaction between a single oral dose of almotriptan 25 mg, a 5-HT1B/1D receptor agonist for the acute treatment of migraine, and food intake in healthy volunteers. The influence of food intake in the rate and extent of almotriptan absorption was evaluated by bioequivalence criteria. Tolerability and safety of treatment were also assessed. 16 healthy volunteers (8 men and 8 women, aged 19-27 years) received a crossed single oral dose of almotriptan 25 mg under fasting and fed conditions, separated by a 7-day washout period. The treatment given under fasting condition was considered as reference. Plasma levels of almotriptan were analyzed using high-performance liquid chromatography (HPLC) and UV detection at 227 nm. The 90% confidence intervals (CI) for the logarithmically transformed Cmax and AUC0-infinity, values of almotriptan under fasting and fed conditions (97.8 - 124% and 102.9 - 108.2%, respectively) fell into the predetermined accepted range of 80 - 125%. No statistically significant differences in Cmax, tmax, AUC0-infinity, MRT and t1/2 were observed under fasting and fed conditions between men and women. Tolerability ...Continue Reading

Citations

Jun 23, 2011·Indian Journal of Pharmaceutical Sciences·A Suneetha, B Syamasundar
Apr 11, 2013·Expert Opinion on Drug Metabolism & Toxicology·Andrea NegroPaolo Martelletti
Jan 15, 2008·Journal of Pharmaceutical and Biomedical Analysis·A Phani KumarB Syama Sundar
Mar 9, 2019·Expert Review of Neurotherapeutics·Julio Pascual, Carlos Vila

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