Choi R L, Sun J X, Kochak G M
Drug Development Department, CIBA-GEIGY Corporation, Ardsley, NY 10502.
Biopharm Drug Dispos. 1993 Dec;14(9):779-84. doi: 10.1002/bdd.2510140904.
The effect of food on the pharmacokinetic disposition of fadrozole hydrochloride was evaluated in nine healthy male and female volunteers. Single 12 mg doses of fadrozole were orally administered to subjects immediately following a standardized meal or after fasting for 12 h, in a randomized crossover design. No statistically significant treatment differences were detected for the pharmacokinetic parameters AUC and half-life. Cmax was significantly reduced by 15% for the fed treatment relative to the fasted treatment, and tmax was delayed by 39%. These findings indicate that the concomitant ingestion of food with fadrozole delays the gastric emptying and/or absorption of fadrozole, but has no effect on the extent of absorption.
在9名健康男性和女性志愿者中评估了食物对盐酸法倔唑药代动力学处置的影响。采用随机交叉设计，在标准化餐后或禁食12小时后，立即给受试者口服单剂量12mg的法倔唑。药代动力学参数AUC和半衰期未检测到统计学上显著的治疗差异。与禁食治疗相比，进食治疗的Cmax显著降低了15%，tmax延迟了39%。这些发现表明，法倔唑与食物同时摄入会延迟法倔唑的胃排空和/或吸收，但对吸收程度没有影响。
