[Translation] Randomized, open-label, fasting and postprandial, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of lenvatinib mesylate capsules (4 mg) in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择Eisai Europe Ltd.为持证商的甲磺酸仑伐替尼胶囊(商品名:乐卫玛®,规格:4mg/粒)为参比制剂,对江苏华阳制药有限公司生产,江苏东科康德药业有限公司提供的受试制剂甲磺酸仑伐替尼胶囊(规格:4mg/粒)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂甲磺酸仑伐替尼胶囊(规格:4mg/粒)和参比制剂甲磺酸仑伐替尼胶囊(商品名:乐卫玛®,规格:4mg/粒)的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, lenvatinib mesylate capsules (trade name: Leweima®, specification: 4mg/capsule) with Eisai Europe Ltd. as the licensee were selected as the reference Preparation, the test preparation lenvatinib mesylate capsules (specification: 4mg/capsule) produced by Jiangsu Huayang Pharmaceutical Co., Ltd. and provided by Jiangsu Dongke Kangde Pharmaceutical Co., Ltd. were administered to humans on an empty stomach and after meals. To compare whether the difference between the absorption rate and degree of absorption of the drug in the test preparation and the reference preparation is within an acceptable range, and evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe healthy volunteers taking the test preparation lenvatinib mesylate capsules (specification: 4 mg/capsule) and the reference preparation lenvatinib mesylate capsules (trade name: Leweima®) orally. , Specifications: 4mg/grain) safety.