Colburn W A, Gibson D M, Wiens R E, Hanigan J J
J Clin Pharmacol. 1983 Nov-Dec;23(11-12):534-9. doi: 10.1002/j.1552-4604.1983.tb01800.x.
Twenty healthy male subjects received 80 mg (2 X 40 mg SEG capsules) oral isotretinoin separated by two-week washout periods in an open randomized crossover design. Isotretinoin was administered during a complete fast, 1 hour after a standard breakfast, with a standard breakfast, or 1 hour before a standard breakfast. Blood samples were obtained at specific times over a 72-hour period. Isotretinoin blood concentrations were determined by a specific HPLC method. The relative bioavailability (AUC) of isotretinoin was found to be approximately 1.5 to 2 times greater when the dose was administered 1 hour before, concomitantly with, or 1 hour after a meal than when it was given during a complete fast. In addition, because the Cmax value is lower when the dose is administered with food rather than 1 hour after a meal, coadministration of isotretinoin with food may be the best method of administration.
20名健康男性受试者采用开放随机交叉设计，接受80毫克（2粒40毫克的SEG胶囊）口服异维A酸，中间间隔两周的洗脱期。异维A酸分别在完全空腹时、标准早餐后1小时、与标准早餐同时服用或标准早餐前1小时给药。在72小时内的特定时间采集血样。采用特定的高效液相色谱法测定异维A酸血药浓度。结果发现，与完全空腹给药相比，异维A酸在进食前1小时、与餐同服或进食后1小时给药时，其相对生物利用度（AUC）约高1.5至2倍。此外，由于与餐同服时的Cmax值低于进食后1小时给药时的Cmax值，异维A酸与食物同服可能是最佳给药方法。
