Study on the Relative Bioavailability of Human Body to 3 Kinds of Telmisartan Preparations
Zhihua Zhang, Peng Wen-xing
Abstract
Zhihua Zhang, Peng Wen-xing
Abstract
OBJECTIVE: To study the bioavailability of human body to 3 kinds of telmisartan preparations. METHODS: 18 healthy male volunteers were randomly divided into 6 groups, who were subjected to 3 periods of crossover study after a single oral dose of 80 mg telmisartan tablet(tested preparation,T1), telmisartan capsule(tested preparation,T2)and Micardis (reference preparation,R),the concentration of telmisartan in plasma was determined by a method of HPLC-MS. RESULTS:The tmax value of T1,T2 and R were(1.5±0.5),(1.5±0.4) and(1.5±0.3)h respectively;the Cmax of which were(794.5± 368.2),(813.9±352.3) and (773.6±357.6)μg/L respectively;AUC0~96 of which were (3 113.2±1 386.2),(3 001.0±1 325.4) and (3 050.6±1 209.4)(μg·h)/L respectively;t1/2 of which were(20.3±5.6),(21.0±7.4) and (20.7±6.4)h respectively. Compared with the R, the relative bioavailability of T1 and T2 were(101.1±12.3)% and (97.4±12.3)% respectively. CONCLUSION:The 3 kinds of telmisartan preparations are bioequivalent in bioavailability.
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OBJECTIVE: To study the bioavailability of human body to 3 kinds of telmisartan preparations. METHODS: 18 healthy male volunteers were randomly divided into 6 groups, who were subjected to 3 periods of crossover study after a single oral dose of 80 mg telmisartan tablet(tested preparation,T1), telmisartan capsule(tested preparation,T2)and Micardis (reference preparation,R),the concentration of telmisartan in plasma was determined by a method of HPLC-MS. RESULTS:The tmax value of T1,T2 and R were(1.5±0.5),(1.5±0.4) and(1.5±0.3)h respectively;the Cmax of which were(794.5± 368.2),(813.9±352.3) and (773.6±357.6)μg/L respectively;AUC0~96 of which were (3 113.2±1 386.2),(3 001.0±1 325.4) and (3 050.6±1 209.4)(μg·h)/L respectively;t1/2 of which were(20.3±5.6),(21.0±7.4) and (20.7±6.4)h respectively. Compared with the R, the relative bioavailability of T1 and T2 were(101.1±12.3)% and (97.4±12.3)% respectively. CONCLUSION:The 3 kinds of telmisartan preparations are bioequivalent in bioavailability.
Key concepts: Telmisartan, Bioavailability, Bioequivalence, Cmax, Chemistry, Chromatography, Pharmacology, Capsule