Thebault J J, Aiache J M, Mazoyer F, Cardot J M
A.S.T.E.R. Hôpital Cognacq-Jay, Paris.
Clin Pharmacokinet. 1987 Oct;13(4):267-72. doi: 10.2165/00003088-198713040-00004.
Food-induced changes in the absorption of Theostat 300, a controlled release formulation of theophylline, have been studied in healthy volunteers. This open, randomised, 3-way, single-dose study involved 12 volunteers who received the drug either while fasting, or with a standardised low-fat (10g), or high-fat (60g) breakfast. Each subject was studied over a 3-week period, with 3 separate days of oral treatment and a 7-day washout period between treatments. The results showed no differences in AUC0-24 and tmax values between the 3 kinds of diet. The only differences observed concerned absorption. Food intake increased Cmax values by 20%. The steady-state peak concentration obtained by means of simulated plasma levels was not influenced by food intake. This slight food-drug interaction of Theostat 300 seemed to be of no clinical significance.
在健康志愿者中研究了食物对控释型茶碱制剂Theostat 300吸收的影响。这项开放、随机、三臂、单剂量研究纳入了12名志愿者，他们在空腹状态下、或与标准化低脂（10克）或高脂（60克）早餐一起服用该药物。每位受试者在3周的时间内接受研究，包括3天的口服治疗，且每次治疗之间有7天的洗脱期。结果显示，三种饮食之间的AUC0-24和tmax值没有差异。观察到的唯一差异与吸收有关。食物摄入使Cmax值增加了20%。通过模拟血浆水平获得的稳态峰浓度不受食物摄入的影响。Theostat 300这种轻微的食物-药物相互作用似乎没有临床意义。
