阿比多尔两种制剂的药代动力学特性和生物等效性:在健康中国男性志愿者中进行的一项开放标签、单剂量、随机序列、两期交叉研究
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刘美美，王珊珊，姚文峰，吴海涛，孟SN，魏俊梅
阿比多尔两种制剂的药代动力学特性和生物等效性:在健康中国男性志愿者中进行的一项开放标签、单剂量、随机序列、两期交叉研究
中华临床杂志2009年4月31日(4):784-92。doi: 10.1016 / j.clinthera.2009.04.016。
- PubMed ID
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19446151 (PubMed视图］
- 摘要
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背景:阿比多是一种抗病毒药物，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，特别是针对甲型和乙型流感，以及严重急性呼吸系统综合征。只要有必要，它就被用来帮助预防流感感染，流感变异的风险很小，使其效果较差。目的:本研究的目的是比较阿比多尔200 mg新开发的分散片剂(试验)和品牌胶囊制剂(参考)在中国健康空腹男性志愿者中的药代动力学特性和耐受性，并确定生物等效性。方法:这项开放标签、单剂量、随机序列、2期交叉研究在健康的中国本土男性志愿者中进行。符合条件的受试者按1:1的比例被随机分配接受单剂量200mg的试验或参考配方，随后是1周的洗脱期和替代配方的管理。研究药物是在夜间禁食12小时后服用的。研究药物给药后，在给药后72小时内采集连续血液样本。采用高效液相色谱-串联质谱法测定血浆药物浓度。通过非区室分析，从两种阿比多尔配方的血药浓度中确定了几个药代动力学参数，包括C(max)、T(max)、T((1/2))、AUC(0-t)和AUC(0-∞)。如果C(max)和AUC的对数转换比在中华人民共和国国家食品药品监督管理局(SFDA)规定的80% ~ 125%的预定生物等效性范围内，则认为制剂具有生物等效性。 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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