Foster T S, Crass R E, Bustrack J A, Smith R B, Munson J W
Am J Hosp Pharm. 1980 Nov;37(11):1528-31.
An open, two-way crossover study of Latin-square design was used to compare the bioavailability of a new capsular formulation of lithium carbonate, Pfi-Lithium (Pfipharmecs Division, Pfizer, Inc.), with that of standard capsular formulation, Eskalith (Smith Kline & French Laboratories). Eighteen healthy, adult male volunteers received both formulations in a randomly determined order. After administration of each 300-mg dose of lithium carbonate, serial blood specimens were obtained. Data obtained from these specimens were subjected to pharmacokinetic evaluation. There were no significant differences (p less than 0.05) in peak plasma concentration, time to peak plasma concentration, and area under the plasma concentration-time curve. These single-dose suggested that the two formulations were bioequivalent.
采用拉丁方设计的开放性双向交叉研究,比较碳酸锂新胶囊制剂Pfi-Lithium(辉瑞公司辉瑞制药部)与标准胶囊制剂Eskalith(史克必成实验室)的生物利用度。18名健康成年男性志愿者按随机确定的顺序接受两种制剂。每次服用300毫克碳酸锂剂量后,采集系列血样。从这些血样中获得的数据进行药代动力学评估。在血浆峰浓度、达峰时间和血浆浓度-时间曲线下面积方面无显著差异(p<0.05)。这些单剂量研究表明两种制剂生物等效。