生物等效性
伐地那非
药代动力学
医学
生物利用度
置信区间
交叉研究
药理学
几何平均数
最大值
曲线下面积
色谱法
他达拉非
勃起功能障碍
内科学
数学
化学
安慰剂
病理
统计
替代医学
作者
Sheng He,Xinyi Wu,Wanggang Zhang,Keli Wang,Yu Chen,Zhibo Zheng,Ting Zhang,Lili Chen,Qing-Qing Duan,Dongyuan He,Binbin Wu
摘要
Abstract Vardenafil hydrochloride tablet is an inhibitor of phosphodiesterase type 5, primarily for the treatment of erectile dysfunction. This postprandial study evaluated the pharmacokinetics and bioequivalence of the test and reference formulations of vardenafil hydrochloride tablets in healthy Chinese volunteers. An open, randomized, single‐center, single‐dose, 2‐period, 2‐sequence bioequivalence test was conducted on 66 healthy subjects under fed conditions. Subjects were randomly assigned to a 20‐mg test or reference formulation with a 7‐day washout period. Venous blood samples (4 mL) were collected from each subject 25 times spanning predose (0 hour) to 24 hours after dosing. The plasma concentration of vardenafil was determined by high‐performance liquid chromatography‐tandem mass spectrometry. Sixty‐two volunteers completed the study. Under fed conditions, the maximum plasma concentration was 29.1 ng/mL, the area under the concentration–time curve (AUC) from time 0 to the time of the last measurable concentration was 85.3 ng•h/mL, and AUC from time 0 to infinity was 87.1 ng•h/mL. The 90% confidence intervals of the geometric mean ratio of AUC time 0 to the time of the last measurable concentration and AUC from time 0 to infinity were within the bioequivalence acceptance range of 0.80‐1.25. The test formulation was a bioequivalent alternative to the reference formulation when taken under fed conditions in healthy Chinese subjects.
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