Title: Bioequivalence of dextromethorphan hydrobromide after administration of orally disintegrating tablets(ODT)
Abstract: Objective:To study the bioequivalence of dextromethorphan hydrobromide after administration of orally disintegrating tablets and dextromethorphan hydrobromide tablets in human.Methods:20 healthy male volunteers were randomly administered with an oral single dose of dextromethorphan hydrobromide orally disintegrating tablets(test formulation)and dextromethorphan hydrobromide tablets(reference formulation) 60 mg.The dextrophan concentration in plasma samples were determined by HPLC-FLD.The pharmacokinetic parameters of two preparations were analyzed using DAS 2.0 program,and the bioequivalence were evaluated by ANOVA and two-one-sided t-test.Results:The pharmacokinetic parameters of test and reference formulations were as follows:t1/2(3.690±1.383)vs.(3.849±1.662)h,Cmax(989.200±232.444)vs.(950.149±208.194)ng·mL-1,Tmax(1.850±0.462)vs.(1.950±0.426)h,AUC0~t(5 308.177±1 245.531)vs.(5 302.158±1 217.175)ng·h·mL-1.The relative bioavailability of the test formulation was(100.7±13.9)%.Conclusion:Dextromethorphan hydrobromide orally disintegrating tablets were bioequivalent to dextromethorphan hydrobromide tablets.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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