Meyer M C, Melikian A P, Straughn A B
J Pharm Sci. 1978 Sep;67(9):1290-3. doi: 10.1002/jps.2600670926.
The relative bioavailability of 400-mg meprobamate tablets manufactured by 11 different firms was evaluated in two groups of healthy male subjects. Each group of six subjects received a reference standard product and five test products given at 1-week intervals. Plasma meprobamate concentrations at 1, 2, 3, 4, 6, 8, 10, 24, and 32 hr after dosing were determined using a GLC assay. Analysis of variance of the plasma level--time profiles revealed no statistically significant differences between any of the products in terms of plasma levels at the various sample times, time of peak plasma level, peak plasma level, and area under the plasma level--time curve. It was concluded that the 11 400-mg products could be considered bioequivalent.
在两组健康男性受试者中评估了11家不同公司生产的400毫克眠尔通片剂的相对生物利用度。每组六名受试者接受一种参比标准产品和五种试验产品,给药间隔为1周。使用气相色谱法测定给药后1、2、3、4、6、8、10、24和32小时的血浆眠尔通浓度。对血浆水平-时间曲线进行方差分析显示,在各个采样时间的血浆水平、血浆峰值水平时间、血浆峰值水平以及血浆水平-时间曲线下面积方面,任何一种产品之间均无统计学上的显著差异。得出的结论是,这11种400毫克的产品可被视为生物等效。