Effect of food intake on the bioavailability of almotriptan, an antimigraine compound, in healthy volunteers: an open, randomized, crossover, single-dose clinical trial.
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 of treatments was good throughout the whole study period. In conclusion, administration of almotriptan 25 mg is bioequivalent under fasting and fed conditions in healthy men and women. Therefore, it is unlikely that concomitant food intake would produce clinially relevant differences in therapeutic effect with almotriptan at the dose studied here.
Jansat
J M
JM
Department of Pharmacokinetics and Drug Metabolism, Almirall Prodesfarma, S.A., Research Center, Laurea Miro 408-410, 08980 Sant Feliu de Llobregat, Barcelona, Spain. jmjansat@almirall.es
Martinez-Tobed
A
A
Garcia
E
E
Cabarrocas
X
X
Costa
J
J
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D018592:Cross-Over Studies; D004435:Eating; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy; D017366:Serotonin Receptor Agonists / Q000493:pharmacokinetics*; D014363:Tryptamines / Q000493:pharmacokinetics*
D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C409045:almotriptan