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CiteWeb id: 20131848369

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This present bioequivalence study was designed to d etermine the bioavailability and bioequivalence of Agomelatine 25 mg tablets in comparison with VALDOXAN ® tablets after single dose administration under fas ting conditions in healthy adult male subjects. Therefore the design of an ope n label, balanced, randomized, single dose, two-tre atment, two-period crossover study with a wash-out period of at least 7 days was used. The pharmacokinetic parameters including C max , AUC 0-t, AUC 0-inf and T max were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (C max , AUC 0-t and AUC 0-inf ) 90%CI were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The 90% confidence intervals for the ratios of the ln-trans formed Cmax and AUC 0→17 for AGOMELATINE were 96.01% and100.94 % respectively. Seventeen volunteers had completed all treatment periods. There was no signi ficant difference between the two formulations. No serious adverse events related to the study drug were foun d.

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