生物等效性
药代动力学
交叉研究
置信区间
医学
不利影响
药理学
随机对照试验
几何平均数
数学
内科学
统计
替代医学
病理
安慰剂
作者
Ping Du,Zhixia Zhao,Weiyue Yu,Rui Zhao,Hongchuan Liu,Pengfei Li,Lihong Liu
标识
DOI:10.1016/j.jddst.2023.104563
摘要
A randomized, open-label, two-period, two-sequence crossover study was carried out for evaluating the bioequivalence of test (T) and reference (R) formulation of gefitinib in healthy Chinese volunteers. A total of eighty subjects were enrolled and randomized into two sequence groups. All subjects were orally administered of T or R formulation at a dose of 250 mg. The plasma samples were obtained at before and after administration until 168 h post-dose, and the drug concentrations were analyzed using validated high-performance liquid chromatography-tandem mass spectrometry method. The 90% confidence interval of the geometric mean ratios were all within the range of 0.80–1.25 under fasting and fed conditions. As for the safety of both formulations, no serious or unexpected adverse events occurred during the study. Overall, the T formulation was bioequivalent with R formulation under fasting and fed conditions.
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