药代动力学
加药
药理学
交叉研究
尿
医学
口服
吸收(声学)
胶囊
不利影响
最大值
化学
内科学
生物
安慰剂
物理
病理
替代医学
植物
声学
作者
Min Wu,Xiaojiao Li,Jixuan Sun,Hong Chen,Yanhua Ding
标识
DOI:10.1080/17425255.2021.1881480
摘要
To evaluate the effect of food on the pharmacokinetics (PK) of fluzoparib capsule.PK data were obtained after fluzoparib treatment in a crossover design study. Single-dose fluzoparib (120 mg) was administered under fasted and fed conditions to 16 healthy subjects. Metabolism and transformation fluzoparib were analyzed by liquid chromatograph-tandem mass spectrometry in the first period. Safety was also assessed.The absorption rate of fluzoparib was slower in the fed group (tmax delayed by 3 h), and peak exposure (Cmax) of fluzoparib in plasma decreased by 19.8% (p < 0.05) compared with the fasted group. The area under the curve (AUC) of fluzoparib was not statistically different between the fasted and fed conditions. The 90% confidence intervals for the Cmax and AUC0-∞ were 69.77-92.24% and 84.88-102.26%, respectively. Five, seven, and five fluzoparib metabolites were isolated from plasma, urine, and feces samples, respectively. Most treatment-emergent adverse events were grade I or II.The presence of food decreased the absorption rate and peak exposure time of fluzoparib; however, the AUC did not significantly change compared with the fasted condition. Therefore, oral administration does not alter the efficacy and safety profile of fluzoparib.
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