Ogunbona F A, Akanni A O
Pharmazie. 1985 Jul;40(7):479.
The bioequivalence of two generics of Ampicillin capsules, hitherto untested, were assessed using Penbritin capsules, the innovator's brand, as the reference product. The bioavailability study was carried out in nine healthy volunteers given one capsule (250 mg) of ampicillin in a completely randomized cross-over design. Statistical analysis (ANOVA) of the results indicated that one of the products tested, designated ampicillin (X), was significantly different (p less than 0.05) in its bioavailability compared to Penbritin while the other product, ampicillin (Helm), was not.
使用创新品牌的盘尼西林胶囊作为参比制剂，对两种此前未经测试的氨苄西林胶囊仿制药的生物等效性进行了评估。生物利用度研究在9名健康志愿者中进行，采用完全随机交叉设计，给予他们一粒（250毫克）氨苄西林胶囊。结果的统计分析（方差分析）表明，所测试的一种产品，即指定为氨苄西林（X）的产品，与盘尼西林相比，其生物利用度有显著差异（p小于0.05），而另一种产品氨苄西林（Helm）则没有。
