Relative bioavailability and pharmacokinetics of domestic glimpiride tablets in volunteers
Ling Ding
Abstract
Ling Ding
Abstract
ABSTRACT:OBJECTIVE The pharmacokinetics and bioavailability of glimpiride tablets were compared with those of imported aventis tablets.METHODS Plasma levels of glimepiride were detected by HPLC UV method.RESULTS The parameters of the two formulations for glimepiride: C max of domestic and imported tablets were ( 415.6 ± 107.3 ) and ( 406.3 ± 150.1 ) μg·L -1 ; T max ( 3.1 ± 0.5 ) and ( 3.2 ± 0.7 ) h; T 1/2 ( 7.3 ± 1.3 ) and ( 7.5 ± 1.7 ) h;AUC 0→t ( 2439.8 ± 598.5 ) and ( 2226.1 ± 458.9 ) μg·L -1 ·h;AUC 0→∞ ( 2635.4 ± 655.8 ) and ( 2402.4 ± 463.9 ) μg·L -1 ·h,respectively.The relative bioavailability of domestic tablets was ( 110.8 ± 18.1 )%.CONCLUSIONS The results of statistics analysis demonstrated that two tablets were bioequivalent.
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ABSTRACT:OBJECTIVE The pharmacokinetics and bioavailability of glimpiride tablets were compared with those of imported aventis tablets.METHODS Plasma levels of glimepiride were detected by HPLC UV method.RESULTS The parameters of the two formulations for glimepiride: C max of domestic and imported tablets were ( 415.6 ± 107.3 ) and ( 406.3 ± 150.1 ) μg·L -1 ; T max ( 3.1 ± 0.5 ) and ( 3.2 ± 0.7 ) h; T 1/2 ( 7.3 ± 1.3 ) and ( 7.5 ± 1.7 ) h;AUC 0→t ( 2439.8 ± 598.5 ) and ( 2226.1 ± 458.9 ) μg·L -1 ·h;AUC 0→∞ ( 2635.4 ± 655.8 ) and ( 2402.4 ± 463.9 ) μg·L -1 ·h,respectively.The relative bioavailability of domestic tablets was ( 110.8 ± 18.1 )%.CONCLUSIONS The results of statistics analysis demonstrated that two tablets were bioequivalent.
Key concepts: Bioequivalence, Bioavailability, Glimepiride, Pharmacokinetics, Plasma concentration, Chemistry, Chromatography, Pharmacology