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ÏÄÌìÏÂÓêÁË(½ð±Ò+20, ·ÒëEPI+1): ºÃ£¬Ð»Ð» 2011-03-09 11:31:10
| After a single oral dose of 10mg of glipizide of two specifications of formulations, by using glipizide controlled-release tablets manufactured by Pfizer Pharmaceutical Co., Ltd. (China. Dalian) as control, bioavailability of glipizide sustained-release capsules manufactured by Harbin Institute of Dragon Chinese medicines was determined as 100.7% and met the related requirements. Analysis of variance showed that no significant difference was found between pharmacokinetic parameters of both formulations so as for as for treatments and cycles, and further test results from two one-sided t test and (1-2a) confidence interval method on Tmax, Cmax, AUC and MRT of both formulations showed reliability of the hypothesis of bioequivalence. From above, a conclusion can be made that the two preparations are bioequivalent. |
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