[Translation] A single-center, randomized, open-label, single-dose, three-sequence, three-period, three-crossover clinical trial evaluating the relative bioavailability and food effects of cimetinib hydrochloride tablets in Chinese healthy subjects
本研究的主要目的为评价中国健康受试者在空腹状态下单次口服盐酸希美替尼片药学变更前后制剂的药代动力学差异及评价食物对中国健康受试者单次口服盐酸希美替尼片药学变更后制剂药代动力学特征的影响;
次要目的为评价中国健康受试者在空腹及餐后状态下单次口服盐酸希美替尼片变更前后制剂的安全性,初步探索中国健康受试者单次口服盐酸希美替尼片药学变更后制剂的代谢产物、物质平衡情况及对QTc间期的影响。
[Translation] The main purpose of this study is to evaluate the pharmacokinetic differences of Chinese healthy subjects before and after a single oral administration of cimetinib hydrochloride tablets before and after the pharmaceutical change in the fasting state and to evaluate the effect of food on a single oral administration of cimetinib hydrochloride in Chinese healthy subjects. The impact on the pharmacokinetic characteristics of the preparation after the change of tablet pharmacy;
The secondary purpose is to evaluate the safety of Chinese healthy subjects before and after a single oral administration of Ximetinib Hydrochloride Tablets under fasting and postprandial states, and to initially explore the safety of Chinese healthy subjects after a single oral administration of Ximetinib Hydrochloride Tablets after pharmaceutical changes. The metabolites of the preparation, the balance of substances and the influence on the QTc interval.