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- W2368492785 abstract "Objective To study the pharmacokinetics of fexofenadine and pseudoephedrine hydrochloride in human after a single and multiple oral dose of Fexofenadine/Pseudoephedrine Sustained-release Tablets and to assess the sustain-release characteristics of pseudoephedrine hydrochloride compared with the conventional preparation of pseudoephedrine hydrochloride and Chlorphenamine Maleate Capsules.Methods An oral single dose and multiple doses of Fexofenadine/Pseudoephedrine Sustained-release Tablets were given to 12healthy volunteers sequentially,respectively.A two-period crossover design was used in the comparison study of the conventional formulation and the sustain-release formulation.An LC/MS/MS method was used for the determination of fexofenadine and pseudoephedrine hydrochloride in human plasma.Results After a single dose administration of Fexofenadine/Pseudoephedrine Sustained-release Tablets,the main pharmacokinetic parameters were as follows:Cmax(133±44)μg·L-1,tmax(2.2± 1.4)h,AUC0-t(1 088±288)μg·h·L-1 and t1/2(9.97±2.14)h for fexofenadine and Cmax(319±47)μg·L-1,tmax(4.0±1.4) h,AUC0-t(4 046±857)μg·h·L-1 and t1/2(5.81±0.93)h for pseudoephedrine hydrochloride.After the multiple doses administration of Fexofenadine/Pseudoephedrine Sustained-release Tablets,the main pharmacokinetic parameters were as follows:Cmax(464±95)μg·L-1,tmax(1.1±0.4)h,AUC0-t(3 005±425)μg·h·L-1 and t1/2(9.81±2.12)h for fexofenadine and Cmax(381 ±54)μg·L-1,tmax(3.1±1.0)h,AUC0-t(4 608±802)μg·h·L-1 and t1/2(5.78±0.47)h for pseudoephedrine hydrochloride.The 90%confidence interval of AUC and Cmax of pseudoephedrine hydrochloride of the sustained-release formulation were 99.6%-119.3%and 77.6%-94.7%,respectively.The tmax was prolonged significantly.Conclusion After administration of Fexofenadine/Pseudoephedrine Sustained-release Tablets,the absorption rate of fexofenadine was rapid and the pseudoephedrine hydrochloride showed the sustained-released characteristics.However the same absoption tendency as the conventional formulation was showed.The concentrations of fexofenadine in plasma of multiple doses administration were significantly higher than that of single dose administration." @default.
- W2368492785 created "2016-06-24" @default.
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- W2368492785 date "2013-01-01" @default.
- W2368492785 modified "2023-09-25" @default.
- W2368492785 title "Pharmacokinetics study of Fexofenadine/Pseudoephedrine Sustained-release Tablets in healthy Chinese volunteers" @default.
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