Niedzielska K, Rosnowska M, Kuran W
Neurol Neurochir Pol. 1986 Sep-Oct;20(5):415-20.
The biological availability was determined of two carbamazepine preparations: Amizepin POLFA and Tegretol GEIGY in tablets. The study was carried out in 10 patients giving them the drug in doses of 400 mg by the crossover method at an interval of 3 weeks. The statistical analysis of the mean maximal values, mean times of reaching of maximal concentrations, and mean areas under the curve of serum carbamazepine concentration changes for both forms of the drug showed a comparable biological availability of Amizepin and Tegretol. The relative degree of bioavailability of Amizepin amounted to 98% of that of Tegretol. The values of pharmacokinetic parameters of both drugs were compared. The value of distribution volume was greater in the case of Tegretol, and the difference was statistically significant. No significant differences were found between the remaining calculated parameters.
测定了两种卡马西平制剂(Amizepin POLFA片剂和Tegretol GEIGY片剂)的生物利用度。该研究在10名患者中进行,采用交叉法,每隔3周给他们服用400毫克药物。对两种药物形式的血清卡马西平浓度变化的平均最大值、达到最大浓度的平均时间以及曲线下平均面积进行统计分析,结果显示Amizepin和Tegretol的生物利用度相当。Amizepin的生物利用度相对程度相当于Tegretol的98%。比较了两种药物的药代动力学参数值。Tegretol的分布容积值更大,差异具有统计学意义。其余计算参数之间未发现显著差异。