Dobrev D, Berndt A, Oertel R, Richter K, Terhaag B, Gramatté T
Institut für Klinische Pharmakologie, Medizinische Fakultät der Technischen Universität Dresden.
Arzneimittelforschung. 1995 Mar;45(3):304-6.
An investigation on the bioavailability of a tablet with 10 mg metoclopramide-HCl (CAS 363-62-5) Cerucal was performed in a two-way cross-over study with 12 volunteers. Metoclopramide was determined in serum by HPLC. The relative bioavailability (mean and nonparametric 95% confidence interval) with respect to a reference preparation was 0.95 (95% CI 0.88-1.02) for AUC and 0.92 (95% CI 0.79-1.07) for Cmax. A positive decision for bioequivalence was derived from the usual confidence intervals for both parameters. The tmax-values did not differ significantly. Statistical evaluation of all parameters revealed bioequivalence between the two preparations.
在一项针对12名志愿者的双向交叉研究中,对含10毫克盐酸甲氧氯普胺(CAS 363 - 62 - 5)的胃复安片的生物利用度进行了研究。通过高效液相色谱法测定血清中的甲氧氯普胺。相对于参比制剂,AUC的相对生物利用度(均值和非参数95%置信区间)为0.95(95% CI 0.88 - 1.02),Cmax的相对生物利用度为0.92(95% CI 0.79 - 1.07)。根据两个参数的常规置信区间得出生物等效性的肯定结论。tmax值无显著差异。对所有参数的统计评估显示两种制剂具有生物等效性。