PMID: 20650049Jul 24, 2010Paper

Comparative bioavailability of two escitalopram formulations in healthy human volunteers

International Journal of Clinical Pharmacology and Therapeutics
G B MendesGilberto De Nucci

Abstract

To assess the bioequivalence of two escitalopram formulations (Test formulation: escitalopram (10 mg tablet) manufactured by Apsen Farmacêutica S.A.) Reference formulation: escitalopram (Lexapro; 10 mg tablet) from Lundbeck Brasil Ltda) in healthy volunteers of both sexes. The study was conducted using an open, randomized, two-period crossover design with at least a 21-day washout interval. Plasma samples were obtained over a 168 h period. Plasma escitalopram concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). The following pharmacokinetic parameters were obtained from the escitalopram plasma concentration vs. time curves: AUC(last), AUC(inf) and C(max). The limit of quantification for escitalopram was 0.2 ng x ml(-1). The geometric mean with corresponding 90% confidence interval (CI) for Test/Reference percent ratios were 97.35% (90% CI = 90.28-104.96%) for C(max), 99.60% (90% CI = 92.93-106.74%) for AUC(last) and 99.92% (90% CI = 93.34-106.97%) for AUC(inf). Since the 90% CI for AUClast, AUCinf and Cmax ratios were within the 80-125% interval proposed by the US FDA, it was concluded that escital...Continue Reading

Citations

Mar 23, 2010·Forensic Science International : Synergy·H M Liversidge
Nov 3, 2010·Journal of Gastroenterology and Hepatology·Vincent Wai-Sun Wong, Henry Lik-Yuen Chan
Jul 16, 2010·Fertility and Sterility·Lu SunJuan Li

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