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首页> 外文期刊>Asian journal of drug metabolism and pharmacokinetics >Pharmacokinetics and relative bioavailability of metformin hydrochloride sustained release tablets in healthy Chinese volunteers
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Pharmacokinetics and relative bioavailability of metformin hydrochloride sustained release tablets in healthy Chinese volunteers

机译：盐酸二甲双胍缓释片在健康中国志愿者体内的药代动力学和相对生物利用度

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Aim To compare pharmacokinetics and relative bioavailability of metformin sustained release tablet(MSRT) and metformin common table t (MCT). Methods 20 male healthy Chinese volunteers were enrolled in a randomized two-way crossover designs with a single-oral dose study (1000 mg once per day for each tablets) and a multi-dose study (1000 mg MSRT once per day and 500mg MCT twice per day). The plasma metformin concentration was determined by HPLC-UV detector. Plasma levels of metformin were followed up to 15 h. Area under the metformin concentration time curve was calculated by variance analysis and the bioequivalent was determined by two one-side t-test. Results A two-compartment model was adopted in metformin plasma concentration-time data analysis. The parameters of MSRT and MCT in single-dose study were as following respectively: C_(max)(1.629+-437 and 2.092+-0.713) mg L~(-1); T_(max)(3.33+-0.73 and 1.69+-0.67) h; MRT(6.57+-0.80 and 4.26+-0.35) h, significantly differences were observed between two products in these three parameters; whereas no significant difference between two products for AUC_(0-infinity)(12.55+-2.95 and 13.18+-2.94 mg L~(-1)centre not h~(-1)) was found, the relative bioavailibility for MSRT was 95.73+-12.10 %. In multi-dose study, no significant difference of the levels of C_(ssav) and C_(ssmin) was found between the two preparations. The fluctuate indexes(FI) for MSRT and MCT were 3.07+-0.69 and 2.52+-0.46, the relative bioavailibility for MSRT was 92.06+-8.57 %. Conclusion The MSRT is bioequivalent to the reference common tablet, and showed the characteristics of sustained release.
机译：目的比较二甲双胍缓释片（MSRT）和二甲双胍通用表t（MCT）的药代动力学和相对生物利用度。方法：20名健康的中国男性自愿者参加了一项随机的双向交叉设计，分别采用单口服剂量研究（每片每天1000 mg）和多剂量研究（每天1000 mg MSRT和500mg MCT两次）每天）。血浆二甲双胍浓度通过HPLC-UV检测器测定。随访血浆二甲双胍水平至15 h。通过方差分析计算二甲双胍浓度时间曲线下的面积，并通过两次单侧t检验确定生物等效量。结果二甲双胍血浆浓度-时间数据分析采用两室模型。单剂量研究中MSRT和MCT的参数分别为：C_（max）（1.629 + -437和2.092 + -0.713）mg L〜（-1）; T_（max）（3.33 + -0.73和1.69 + -0.67）h; MRT（6.57 + -0.80和4.26 + -0.35）h，在这三个参数中，两种产品之间观察到显着差异;而AUC_（0-infinity）（12.55 + -2.95和13.18 + -2.94 mg L〜（-1）中心而非h〜（-1））的两种产物之间无显着差异，MSRT的相对生物利用度为95.73 + -12.10％。在多剂量研究中，两种制剂之间的C_（ssav）和C_（ssmin）水平没有显着差异。 MSRT和MCT的波动指数（FI）分别为3.07 + -0.69和2.52 + -0.46，MSRT的相对生物利用度为92.06 + -8.57％。结论MSRT与参考普通片剂具有生物等效性，并具有持续释放的特征。

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