Roscoe R, Cooper J, Wilson T W, Joshi N N, Midha K K
Biopharm Drug Dispos. 1982 Apr-Jun;3(2):105-14. doi: 10.1002/bdd.2510030204.
A relative bioavailability study of conventional tablet of propranolol hydrochloride was conducted in a group of 18 healthy volunteers employing the innovator's product as the reference tablet formation. Based on plasma levels of propranolol for the 24 h following administration of 2 x 40 mg oral propranolol hydrochloride tablets, the relative extent of availability was shown to be 100.8 per cent for the test tablet formulation; no significant differences were detected between formulations with respect to any of the pharmacokinetic parameters examined. Large intersubject variations in plasma propranolol concentrations and the subsequently calculated areas under the plasma concentration/time curves were attributed to substantial presystemic biotransformation differences.
以创新产品作为参比制剂,在18名健康志愿者中进行了盐酸普萘洛尔普通片的相对生物利用度研究。根据口服2×40mg盐酸普萘洛尔片后24小时的血浆普萘洛尔水平,测试片制剂的相对生物利用度为100.8%;在所检测的任何药代动力学参数方面,各制剂之间均未检测到显著差异。血浆普萘洛尔浓度以及随后计算的血浆浓度/时间曲线下面积存在较大的个体间差异,这归因于显著的首过生物转化差异。