Sved S, McGilveray I J, Beaudoin N
J Pharm Sci. 1977 Dec;66(12):1761-4. doi: 10.1002/jps.2600661228.
The bioavailability of three isoniazid formulations was assessed using a procedure specific for the free drug. Nine human volunteers, all slow acetylators, were each given 4 X 100 mg of isoniazid of three different tablet formulations at weekly intervals; the plasma drug levels were measured at different times during the first 24 hr. No significant differences (p greater than 0.05) were detected among the three products as to relative bioavailability, peak plasma concentrations, Cmax, and the time of Cmax, tmax. Analysis of variance of the pharmacokinetic parameters obtained according to a one-compartment open model did not demonstrate any significant formulation or time effect but revealed a significant intersubject variation in all parameters involved.
采用针对游离药物的特定方法评估了三种异烟肼制剂的生物利用度。九名人类志愿者均为慢乙酰化者,每周一次分别给予三种不同片剂剂型的4×100mg异烟肼;在最初24小时内的不同时间测量血浆药物水平。在三种产品之间,未检测到相对生物利用度、血浆峰浓度、Cmax以及Cmax出现时间tmax存在显著差异(p大于0.05)。根据单室开放模型获得的药代动力学参数的方差分析未显示任何显著的剂型或时间效应,但揭示了所有相关参数存在显著的个体间差异。