Francisco G E, Honigberg I L, Stewart J T, Kotzan J A, Brown W J, Schary W L, Pelsor F R, Shah V P
Biopharm Drug Dispos. 1984 Oct-Dec;5(4):335-44. doi: 10.1002/bdd.2510050405.
The purpose of the study was to examine the bioequivalence of five commercially available oral prednisone products. The in vivo study utilized 18 healthy males, each of whom was administered 20 mg of prednisone as a reference solution or as a tablet in a 6-week, six-way crossover design. Blood was collected and serum was assayed, using an HPLC procedure specific for prednisone and prednisolone. Mean pharmacokinetic parameters (t 1/2, ke, Cmax, tmax, and AUC) were determined. ANOVA was performed on the prednisone and prednisolone data (F-test, p less than 0.05) as well as Duncan's multiple range analysis. Dissolution tests were also performed on each of the five products in order to test the relationship between dissolution and bioequivalence among prednisone products. The in vitro study consisted of a standard USP dissolution test which included tablets from the same lots as the tablets used in the in vivo study. The data showed no statistical difference in any of the pharmacokinetic parameters among tableted products, subjects, or dosing periods in the study. There was also no statistical difference in the dissolution study among the five commercial tablet forms.
该研究的目的是检验五种市售口服泼尼松产品的生物等效性。体内研究使用了18名健康男性，每个人都按照6周的六交叉设计，以参比溶液或片剂的形式服用20 mg泼尼松。采集血液并检测血清，采用一种针对泼尼松和泼尼松龙的高效液相色谱法。测定了平均药代动力学参数（t1/2、ke、Cmax、tmax和AUC）。对泼尼松和泼尼松龙的数据进行了方差分析（F检验，p<0.05）以及邓肯多重极差分析。还对五种产品中的每一种进行了溶出度试验，以检验泼尼松产品溶出度与生物等效性之间的关系。体外研究包括一项标准的美国药典溶出度试验，其中使用了与体内研究中所用片剂相同批次的片剂。数据表明，在该研究中，片剂产品、受试者或给药周期之间的任何药代动力学参数均无统计学差异。五种市售片剂剂型之间的溶出度研究也没有统计学差异。
