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2011•The Chinese Journal of Modern Applied PharmacyRequires access

Pharmacokinetics and Bioequivalence of Two Tiopronin Preparations in Healthy Volunteers

Liu Yang

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Abstract

OBJECTIVE To study the pharmacokinetics and bioequivalence of two tiopromin preparations in healthy volunteers.METHODS Tiopromin concentrations of the test and the reference tablets in plasma were determined by LC-MS/MS,the pharmacokinetic parameters were calculated by DAS software,and then their bioequivalene in healthy volunteers was studied.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follows: t1/2 were(12.8±5.3) and(10.8±4.6) min;Cmax were(7.02±1.35) and(7.16±0.81) g·mL-1;AUC0-t were(44.0±8.3) and(45.5±6.5) g·h·mL-1,AUC0-∞ were(50.1±10.7) and(50.7±9.5) g·h·mL-1,respectively.The relative bioavailability of tiopronin test and reference tablets was(96.8±11.5)%.CONCLUSION The main pharmacokinetics parameters of two preparations have no significant difference.The results demonstrated that the two preparations were bioequivalent.

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OBJECTIVE To study the pharmacokinetics and bioequivalence of two tiopromin preparations in healthy volunteers.METHODS Tiopromin concentrations of the test and the reference tablets in plasma were determined by LC-MS/MS,the pharmacokinetic parameters were calculated by DAS software,and then their bioequivalene in healthy volunteers was studied.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follows: t1/2 were(12.8±5.3) and(10.8±4.6) min;Cmax were(7.02±1.35) and(7.16±0.81) g·mL-1;AUC0-t were(44.0±8.3) and(45.5±6.5) g·h·mL-1,AUC0-∞ were(50.1±10.7) and(50.7±9.5) g·h·mL-1,respectively.The relative bioavailability of tiopronin test and reference tablets was(96.8±11.5)%.CONCLUSION The main pharmacokinetics parameters of two preparations have no significant difference.The results demonstrated that the two preparations were bioequivalent.

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Available abstract

OBJECTIVE To study the pharmacokinetics and bioequivalence of two tiopromin preparations in healthy volunteers.METHODS Tiopromin concentrations of the test and the reference tablets in plasma were determined by LC-MS/MS,the pharmacokinetic parameters were calculated by DAS software,and then their bioequivalene in healthy volunteers was studied.RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follows: t1/2 were(12.8±5.3) and(10.8±4.6) min;Cmax were(7.02±1.35) and(7.16±0.81) g·mL-1;AUC0-t were(44.0±8.3) and(45.5±6.5) g·h·mL-1,AUC0-∞ were(50.1±10.7) and(50.7±9.5) g·h·mL-1,respectively.The relative bioavailability of tiopronin test and reference tablets was(96.8±11.5)%.CONCLUSION The main pharmacokinetics parameters of two preparations have no significant difference.The results demonstrated that the two preparations were bioequivalent.

Key concepts: Bioequivalence, Pharmacokinetics, Cmax, Bioavailability, Tiopronin, Pharmacology, Plasma concentration, Significant difference

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