Meyer M C, Straughn A B, Ramachander G, Cavagnol J C, Biola Mabadeje A F
J Pharm Sci. 1978 Dec;67(12):1659-61. doi: 10.1002/jps.2600671205.
A four-way crossover sulfadiazine bioavailability study was conducted in 16 normal healthy male volunteers. The subjects were divided into groups of eight. Each group received four different oral dosage forms of sulfadiazine at 1-week intervals: a solution as a reference, a suspension, and two different tablets. All dosage forms were equivalent to 500 mg of sulfadiazine. Blood samples were obtained at 0, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 25.0, 33.0, and 49.0 hr. Analysis of variance indicated no statistically significant difference (p more than 0.05) between the dosage forms in terms of area under the plasma level--time curve, peak plasma concentration, and time of peak plasma concentration. In both groups, there were differences between products at isolated sampling times. It was concluded that the four tablet formulations of sulfadiazine exhibited bioavailability characteristics equivalent to those of the solution and the suspension.
在16名正常健康男性志愿者中进行了一项关于磺胺嘧啶生物利用度的四交叉研究。受试者被分成每组8人的两组。每组在1周的间隔内接受四种不同口服剂型的磺胺嘧啶：一种溶液作为对照、一种混悬液以及两种不同的片剂。所有剂型均相当于500mg磺胺嘧啶。在0、0.5、1.0、2.0、3.0、4.0、6.0、8.0、10.0、25.0、33.0和49.0小时采集血样。方差分析表明，各剂型在血浆浓度-时间曲线下面积、血浆峰浓度及血浆峰浓度出现时间方面无统计学显著差异（p＞0.05）。在两组中，在单独的采样时间点，不同产品之间存在差异。得出的结论是，四种磺胺嘧啶片剂制剂的生物利用度特征与溶液剂和混悬液相当。
