Comparison of the Bioavailabilities of Two Medicinal Formulations of Fampridine in Healthy Volunteers

Autor:	V. G. Belolipetskaya, V. S. Arnautov, A. V. Belostotskii, E. K. Zakharova, D. V. Reikhart
Rok vydání:	2015
Předmět:	Pharmacology Animal science Chemistry Drug Discovery Healthy volunteers Pharmacology toxicology Cmax Bioequivalence Geometric mean Crossover study Confidence interval Bioavailability
Zdroj:	Pharmaceutical Chemistry Journal. 49:477-480
ISSN:	1573-9031 0091-150X
DOI:	10.1007/s11094-015-1309-6
Popis:	The bioavailabilities of two medicinal formulations of fampridine – fampridine slow-release tablets, 10 mg (study agent, OAO Valenta Farmatsevtika, Russia) and Fampyra slow-release tablets, 10 mg (reference agent, Biogen Idec Ltd., UK) were compared in an open, randomized, crossover study using single 10-mg doses. Mean (± SD) C max was 27.28 ± 4.33 ng/ml for reference agent and 26.63 ± 3.44 ng/ml for study agent. Mean AUC values were 302.56 ± 56.23 and 300.57 ± 55.24 ng.h/ml respectively. The 90% confidence interval for geometrical mean C max and AUC were in the ranges 91 – 105% for C max and 90 – 109% for AUC. The boundaries of the 90% confidence intervals were in the acceptable range (80 – 125%), complying with the requirements for confirming the bioequivalence of the agents being compared.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::5b529e0bbef864aa8436743123b4ce05 https://doi.org/10.1007/s11094-015-1309-6 Zobrazit plný text záznamu Plný text ve formátu PDF