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Biavailability Section

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

J.M. Jansat, A. Martinez-Tobed, E. Garcia, X. Cabarrocas and J. Costa

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Volume 44 p. 185 - 190

Abstract

J.M. Jansat¹, A. Martinez-Tobed¹, E. Garcia², X. Cabarrocas² and J. Costa³

¹Department of Pharmacokinetics and Drug Metabolism and ²Medical Department, Almirall Prodesfarma S.A., Barcelona, Spain
³Department of Clinical Pharmacology, Hospital Universitari “Germans Trias i Pujol”, Universitat Autònoma de Barcelona, Spain
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-¥ 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-¥, 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 clinically relevant differences in therapeutic effect with almotriptan at the dose studied here. Correspondence to:
J.M. Jansat, MD
Department of Pharmacokinetics and Drug Metabolism
Almirall Prodesfarma, S.A., Research Center
Laurea Miro 408-410
08980 Sant Feliu de Llobregat, Barcelona, Spain
Email: [email protected]

Bioavailability Section

Ethanol does not significantly affect the bioavailability of almotriptan: an open, randomized, crossover, single-dose, phase I clinical trial in healthy volunteers

X. Cabarrocas, M. Salva, M. Pavesi and J. Costa

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42.00 $

Volume 44 p. 443 - 448

Abstract

X. Cabarrocas¹, M. Salva¹, M. Pavesi¹ and J. Costa²

¹Research Center, Almirall Prodesfarma, Barcelona, and ²Clinical Pharmacology Department, Hospital Universitario “Germans Trias i Pujol”, Universitat Autonoma de Barcelona, Badalona, Spain
Objective: A number of clinical reports have revealed a link between the use of alcohol and the onset or exacerbation of migraine headaches. This open, randomized, crossover, single-dose, phase I clinical trial evaluated the possible pharmacokinetic interactions between a single oral dose of almotriptan 12.5 mg, a 5-HT1B/1D receptor agonist for the acute treatment of migraine, and ethanol in 16 healthy male volunteers. Tolerability and safety of this combined treatment were also assessed. Methods: Subjects received a crossed oral dose of almotriptan (12.5 mg) with and without concomitant alcohol intake (target plasma concentration 0.8 g/kg) in two different treatment periods. Almotriptan was administered alone, while ethanol was diluted with orange juice, which was also given to the control group. There was a washout period of 7 days between treatments. Plasma levels of almotriptan were analyzed using a sensitive and specific liquid chromatographic-tandem mass spectrometry method. Results: The 90% non-parametric confidence interval for the median tmax of almotriptan plus ethanol compared to almotriptan alone (0.61/2.72) was outside the acceptable range (0.70 – 1.30), demonstrating that concomitant ethanol administration slightly increases the variability of absorption of almotriptan 12.5 mg. In contrast, the main bioavailability criteria parameters, Cmax and AUC, which show the rate and extent of systemic absorption, were not affected by alcohol ingestion. Therefore, it is unlikely that concomitant ethanol intake would produce clinically relevant differences in the therapeutic effect of almotriptan at the dose studied here. Tolerability of treatments was good throughout the entire study period. Conclusions: Almotriptan 12.5 mg, with or without concomitant alcohol ingestion, showed similar plasma concentrations after a single dose in healthy volunteers with no clinically relevant drug-to-drug interactions.Correspondence to:
J. Costa, MD
Clinical Pharmacology Department
University Hospital Germans Trias i Pujol
Ctra. de Canyet s/n; 08916 Badalona, Spain
Email: [email protected]

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