Title: Bioequivalence of domestic and imported nicergoline tablets in healthy volunteers
Abstract: Objective To study the bioequivalence of domestic and imported nicergoline tablets in healthy volunteers.Methods An open randomized,two period crossover study on 18 healthy male volunteers was carried out with orally test drug(domestic) and reference drug(imported) nicergoline tablets.The concentrations of nicergoline primary metabolites 6-dimethyl-8β-hydroxymethyl-10α-methoxy-nicergoline(MDL) in plasma were determined by LC-MS.The pharmacokinetic parameters and relative bioavalibility were calculated to evaluate the bioequivalence between the two kinds tablets by DAS 2.1 software.Results The main pharmacokinetic parameters of test and reference drugs were as follows: Cmaxwere(21.94±10.10) and(23.48±11.10) ng·mL-1;Tmax were(2.78±0.73) and(3.00±0.84) h;AUC0-60 were(264.47±134.26) and(272.77±134.35) ng·h·mL-1;AUC0-∞were(286.14±140.34) and(293.38±138.86) ng·h·mL-1;t1/2 were(12.13±4.26) and(12.07± 4.29) h,respectively.The relative bioavailability of nicergoline was(98.6±23.5)%.Conclusion The results of statistical analysis shown that the two drugs were bioequivalent.
Publication Year: 2012
Publication Date: 2012-01-01
Language: en
Type: article
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Cited By Count: 1
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