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- W2392497951 abstract "OBJECTIVE:To study the bioequivalence of Racecadotril pulvis and Racecadotril granules.METHODS:A randomized crossover design was performed in 20 healthy male volunteers.A single oral dose of Racecadotril pulvis(200 mg,test preparation) or Racecadotril granules(200 mg,reference preparation) were administrated.Plasma concentrations of racecadotril were determined by LC-MS.The pharmacokinetic parameters were calculated by DAS 2.0 software and the bioequivalence was evaluated.RESULTS:After a single oral dose of 200 mg test preparation or reference preparation,the main pharmacokinetic parameters were as follows:cmax(286.54±66.14)ng·mL-1 and(283.73±65.49)ng·mL-1;tmax(1.78±0.48)h and(1.68±0.79) h;t1/2(4.02±1.26) h and(4.00±1.11) h;AUC0～24 h(1 353±431) ng·h·mL-1 and(1 293±320)ng·h·mL-1.There was no significant difference between the two preparations in pharmacokinetic parameters by variance analysis,t test and 1-2α confidence interval method(P0.05).The 90% confidence intervals of cmax,AUC0～24 h and AUC0～∞of test preparation were 92.2%～111.1%,98.1%～107.7% and 98.6%～108.3%.CONCLUSION:Racecadotril pulvis and Racecadotril granules are bioequivalent in healthy volunteers." @default.
- W2392497951 created "2016-06-24" @default.
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- W2392497951 date "2012-01-01" @default.
- W2392497951 modified "2023-09-22" @default.
- W2392497951 title "Study on the Bioequivalence of 2 Kinds of Racecadotril Preparations in Healthy Volunteers" @default.
- W2392497951 hasPublicationYear "2012" @default.
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