Rimoy G H, Idle J R, Bhaskar N K, Rubin P C
Department of Therapeutics, University Hospital, Queen's Medical Centre, Nottingham.
Br J Clin Pharmacol. 1989 Nov;28(5):612-5. doi: 10.1111/j.1365-2125.1989.tb03551.x.
Previous studies following single dose administration have suggested that the pharmacokinetics of various nifedipine formulations could be influenced by the timing of associated food consumption. In order more closely to reflect the clinical situation we have carried out a study at steady state using a 'biphasic' formulation comprising 'rapid' and 'retarded' drug release components. Fifteen normal subjects took 20 mg 'biphasic' nifedipine 12 hourly for 10 days. Studies were carried out on days 4, 7 and 10. On these days the nifedipine was taken 2 h or 1 h before or immediately following a light breakfast. A light breakfast influenced neither the rate nor the extent of nifedipine absorption nor the rate or extent of major metabolite appearance. We conclude that at steady state the timing of a light meal is unlikely to alter in any clinically important manner the pharmacokinetics of nifedipine released from 'biphasic' tablets.
先前的单剂量给药研究表明，各种硝苯地平制剂的药代动力学可能会受到进食时间的影响。为了更准确地反映临床情况，我们使用了一种包含“速释”和“缓释”药物释放成分的“双相”制剂进行了一项稳态研究。15名正常受试者每12小时服用20毫克“双相”硝苯地平，持续10天。在第4天、第7天和第10天进行研究。在这些日子里，硝苯地平在清淡早餐前2小时或1小时或紧随其后服用。清淡早餐既不影响硝苯地平的吸收速率和程度，也不影响主要代谢产物的出现速率或程度。我们得出结论，在稳态下，清淡饮食的时间不太可能以任何具有临床重要意义的方式改变从“双相”片剂中释放的硝苯地平的药代动力学。
