/ Not yet recruitingPhase 1 [Translation] Bioequivalence study of metformin hydrochloride sustained-release tablets in humans
以健康男性志愿者为试验对象,采用单剂量单次给药及单剂量多次给药的自身交叉对照的试验设计,考察申办者生产的盐酸二甲双胍缓释片(受试制剂)与Bristol-Myers Squibb Company生产的盐酸二甲双胍缓释片(格华止)(参比制剂)的相关药代动力学参数及相对生物利用度,评价两种制剂间的生物等效性。
[Translation] Healthy male volunteers were used as test subjects. A self-crossover control experimental design of single-dose single administration and single-dose multiple administration was adopted to investigate the relevant pharmacokinetic parameters and relative bioavailability of metformin hydrochloride sustained-release tablets produced by the applicant (test preparation) and metformin hydrochloride sustained-release tablets (Glucophage) produced by Bristol-Myers Squibb Company (reference preparation), and to evaluate the bioequivalence between the two preparations.
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