Abstract：
This study aimed to evaluate the bioequivalence of two pazopanib tablet formulations in healthy Chinese subjects. A randomized, open-label, single-dose, two-period, two-sequence, crossover study was conducted under fasting conditions. A total of 32 eligible subjects were randomly administered a single dose of a 200-mg generic or branded pazopanib tablet with a 16-day washout period. Blood samples were collected before and up to 72 hours after dosing. Pharmacokinetic parameters were analyzed with noncompartmental analysis. Safety assessments included physical examinations, laboratory tests, and adverse events reporting. Maximum plasma concentration (Cmax ), area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t ), and AUC from zero to infinity (AUC0-∞ ) were similar between the generic and branded products (all P > .05). The 90% confidence intervals of the geometric mean ratio of the test/reference products for Cmax , AUC0-t , and AUC0-∞ were 89.1%-117.1%, 81.9%-108.5%, and 82.4%-109.6%, respectively. There were no serious adverse events during the study. The newly developed generic pazopanib tablet was bioequivalent to the reference product under fasting conditions. Both formulations were well tolerated in healthy Chinese volunteers.
摘要：
本研究旨在评估两种帕唑帕尼片剂在健康中国受试者中的生物等效性。一个随机的，开放标签，单剂量,两期,两个序列，交叉研究是在禁食条件下进行的。总共32名符合条件的受试者被随机给予单剂量的200毫克通用或品牌帕唑帕尼片，冲洗期16天。在给药前和给药后72小时收集血样。用非房室分析分析药代动力学参数。安全性评估包括体检,实验室测试,和不良事件报告。最大血浆浓度（Cmax），血浆浓度-时间曲线下面积（AUC）从零到最后一个可量化浓度（AUC0-t），从零到无穷大的AUC（AUC0-∞）在通用产品和品牌产品之间相似（所有P>.05）。Cmax测试/参考产品的几何平均比的90%置信区间，AUC0-t,AUC0-∞为89.1%-117.1%，81.9%-108.5%，和82.4%-109.6%，分别。研究期间无严重不良事件发生。新开发的通用帕唑帕尼片剂在禁食条件下与参考产品生物等效。两种制剂在健康的中国志愿者中都具有良好的耐受性。
