arbidol的药代动力学性质和生物等效性的两个公式:一个非盲、单剂,randomized-sequence,两年期交叉研究在中国健康男性志愿者。

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刘我,王,姚明WF,吴赫兹,孟SN,魏乔丹

arbidol的药代动力学性质和生物等效性的两个公式:一个非盲、单剂,randomized-sequence,两年期交叉研究在中国健康男性志愿者。

其他。2009年4月,31 (4):784 - 92。doi: 10.1016 / j.clinthera.2009.04.016。

PubMed ID
19446151 (在PubMed
]
文摘

背景:Arbidol是一种抗病毒药物用于预防和治疗所有类型的流感感染和一些其他类型的急性呼吸道感染,针对流感A和B组,和严重急性呼吸系统综合症。它是用来帮助预防流感感染只要有必要很少患流感变异使其不那么有效。目的:本研究的目的是比较药代动力学性质和耐受性,并确定生物等效性,新开发的通用分散型平板配方(测试)和品牌胶囊配方(引用)arbidol 200毫克健康男性志愿者中国禁食。方法:这种非盲、单剂、randomized-sequence -周期交叉研究是在中国人健康男性志愿者进行的。合格的受试者被随机分配在1:1的比例来接收一个200毫克剂量的测试或参考配方,后跟一个1周,洗脱期和管理的替代配方。研究药物注射后迅速一整夜。研究药物管理局后,连续收集血液样本72小时后管理。血浆药物浓度测定用高性能液相色谱法耦合串联质谱分析。几个药代动力学pararameters,包括C (max)、T (max)、T ((1/2)), AUC (0-t)和AUC (0-infinity),测定血浆浓度的2配方arbidol使用noncompartmental分析。配方被认为bioequivalent如果C的对数转换比率(max)和AUC是80%到125%的预先确定的生物等效性范围内建立了由国家食品药品监督管理局(SFDA)的中华人民共和国。 Tolerability was assessed by monitoring vital signs (blood pressure, heart rate, temperature, and electrocardiography), laboratory analysis (hematology, blood biochemistry, hepatic function, and urinalysis), and subject interview on adverse events. RESULTS: Twenty subjects were enrolled and completed the study (mean [SD] age, 21.1 [1.1] years; weight, 64.7 [5.1] kg; and height, 172.3 [3.1] cm). Neither period nor sequence effect was observed. The main pharmacokinetic properties with the test and reference formulations were as follows: C(max), 417.4 (107.6) and 414.8 (95.1) ng/mL, respectively (P = NS); median (range) T(max), 0.63 (0.25-1.0) and 0.75 (0.5-1.5) hours (P = 0.035); AUC(0-t), 2033.6 (564.9) and 1992.0 (483.3) ng/mL/h (P = NS); AUC(0-infinity), 2285.4 (597.7) and 2215.2 (604.0) ng/mL/h (P = NS); and t(1/2), 6.9 (4.2) and 6.1 (5.2) hours (P = NS). The 90% CIs for the log-transformed ratios of C(max), AUC(0-t), and AUC(0-infinity) were 91.7% to 109.7%, 91.0% to 112.8%, and 92.0% to 116.3%, respectively (all, P < 0.05), which were within the predetermined range for bioequivalence. No adverse events were found on analysis of vital signs or laboratory tests or reported by subjects in this study. CONCLUSION: In this study in healthy Chinese male volunteers, the dispersible tablet formulation and the 200-mg capsule formulation of arbidol met the SFDA's regulatory definition of bioequivalence based on the rate and extent of absorption.

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