McGilveray I J, Midha K K, Loo J C, Cooper J K
Int J Clin Pharmacol Biopharm. 1978 Mar;16(3):110-5.
A bioavailability study of eight commercial pharmaceutically equivalent tablet formulations and a solution of metronidazole was conducted in groups of ten subjects with single oral 250 mg doses. Although the solution gave significantly lower extents of bioavailability, the commercial tablets were not significantly different from the (innovator) reference product. The slow rate of absorption for one formulation (F) was observed to be associated with long dissolution time. Individual elimination half-life differences (probably attributable to metabolism) were reflected in considerable intersubject differences in plasma metronidazole concentrations.
对十组受试者单次口服250毫克剂量的八种商业药学等效片剂制剂和甲硝唑溶液进行了生物利用度研究。尽管溶液的生物利用度显著较低,但商业片剂与(创新者)参比产品并无显著差异。观察到一种制剂(F)吸收速度缓慢与溶解时间长有关。个体消除半衰期差异(可能归因于代谢)反映在血浆甲硝唑浓度的显著个体间差异上。