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- W2373810261 abstract "OBJECTIVE:To study the pharmacokinetics and relative bioavailability of Gliclazide sustained-release tablets,and to validate the bioequivalence between the domestic and the imported Gliclazide sustained-release tablets.METHODS:In Latin square experiment,32 healthy volunteers were given single and multiple oral-dose of Gliclazide sustained-release tablet in foodless condition,and pharmacokinetics and bioequivalence of the two formulations were evaluated and the plasma concentrations were de-termined by HPLC.RESULTS:The main pharmacokinetic parameters of domestic preparation vs.imported preparation after singleoral-dose of Gliclazide sustained-release tablets were as followst:max(6.71±1.43)h vs.(7.38±1.50)h;Cmax(0.813±0.178)μg.mL-1vs.(0.782±0.129)μg.mL-1;AUC0~72(21.29±5.86)μg.h.mL-1 vs.(21.09±5.34)μg.h.mL-1;AUC0~∞(23.19±7.49)μg.h.mL-1vs.(23.15±5.64)μg.h.mL-1;t1/2ke(18.79±5.24)h vs.(20.03±5.67)h.The main steady state pharmacokinetic parameters of do-mestic preparation vs.imported preparation after the multiple-dose of Gliclazide sustained-release tablets were as follows:AUCss(27.85±9.77)μg.h.mL-1 vs.(27.63±10.84)μg.h.mL-1;Cssmax(1.892±0.503)μg.mL-1 vs.(1.829±0.521)μg.mL-1;tssmax(5.33±1.24)h vs.(6.13±1.42)h;Cssmin(0.771±0.379)μg.mL-1 vs.(0.830±0.478)μg.mL-1;DF:(103.8±40.0)% vs.(97.6±52.9)%.CONCLUSION:The two preparations are bioequivalent." @default.
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- W2373810261 date "2010-01-01" @default.
- W2373810261 modified "2023-09-23" @default.
- W2373810261 title "Study on Pharmacokinetics and Bioequivalence of Gliclazide Sustained-release Tablets in Healthy Volunteers" @default.
- W2373810261 hasPublicationYear "2010" @default.
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