Title: Bioequivalence of nicergoline tablets in healthy volunteers
Abstract: AIM:To study the pharmacokinetics and bioequivalence of nicergoline tablets in healthy volunteers.METHODS:A single oral dose(20 mg test or reference formulation)was given to 20 healthy volunteers according to an open randomized crossover design.10α-methoxy-9,10-dihydrolysergol(MDL) is a major metabolite of nicergoline,the concentration of MDL in plasma was determined by LC-MS.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.RESULTS:The main pharmacokinetic parameters of nicergoline tablets were as follows:tmax were(3.3±0.9)and(3.2±0.7) h,t1/2 were(12.9±4.0)and(12.8±2.4) h,Cmax were(23±6)and(22±6) μg/L;AUC0-t were(291±51)and(282±44)μg·L-1·h;AUC0-∞ were(316±50)and(299±46) μg·L-1·h.The relative bioavailability of two formulations was(104±17)%.CONCLUSION:The two nicergoline formulations are bioequivalent.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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Cited By Count: 1
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