Boner A L, Sette L, Messori A, Plebani M, Vallone G, Martini N
Clinica Pediatrica, University of Verona, Siena, Italy.
J Clin Pharm Ther. 1988 Feb;13(1):77-81. doi: 10.1111/j.1365-2710.1988.tb00509.x.
A study was conducted in two groups of healthy volunteers to assess whether the time of administration (10 min before the meal versus 60 min after the meal) influences the pharmacokinetics and absorption kinetics of a slow-release theophylline product (Teonova). In the first group (Group A, n = 10), the drug was given in a paired-sample design as a single dose of 600 mg before and after breakfast with an interval of at least 1 week between the two administrations. In the second group (Group B, n = 10), Teonova was given by the same study design before and after dinner. In all cases, time curves of theophylline plasma levels were determined by collecting serial blood samples 24 h after dosing and analysed pharmacokinetically through model-independent methods. In Group A, curves obtained before and after the meal were fully superimposable, and no difference was found between the pharmacokinetic parameters determined in either condition. The same result was obtained in Group B. Our results indicate that, after single dose, the two different times of administration that we tested were equivalent in pharmacokinetic terms.
在两组健康志愿者中开展了一项研究，以评估给药时间（饭前10分钟与饭后60分钟）是否会影响缓释型茶碱产品（Teonova）的药代动力学和吸收动力学。在第一组（A组，n = 10）中，采用配对样本设计，在早餐前后分别给予单剂量600 mg药物，两次给药间隔至少1周。在第二组（B组，n = 10）中，按照相同的研究设计在晚餐前后给予Teonova。在所有情况下，通过给药后24小时采集系列血样来测定茶碱血浆水平的时间曲线，并通过非模型依赖方法进行药代动力学分析。在A组中，饭前和饭后获得的曲线完全重叠，两种情况下测定的药代动力学参数之间未发现差异。B组也得到了相同的结果。我们的结果表明，单剂量给药后，我们测试的两种不同给药时间在药代动力学方面是等效的。
