[Translation] To evaluate the single-center, open-label, randomized, controlled trial of the test preparation Palonosetron Hydrochloride Soft Capsules (specification: 0.5 mg) and the reference preparation Aloxi® (specification: 0.5 mg) in healthy adult subjects under fasting and postprandial conditions. Single-dose, two-cycle, two-sequence, crossover bioequivalence study
主要研究目的:评估空腹和餐后状态下单次口服受试制剂盐酸帕洛诺司琼软胶囊(规格:0.5 mg,持证商:河南泰丰生物科技有限公司)与参比制剂盐酸帕洛诺司琼软胶囊(Aloxi®,规格:0.5 mg,持证商:Helsinn Birex Pharmaceuticals Ltd.)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸帕洛诺司琼软胶囊(规格:0.5 mg)与参比制剂盐酸帕洛诺司琼软胶囊(Aloxi®,规格:0.5 mg)在健康受试者中的安全性。
[Translation] Main research purpose: To evaluate the single oral administration of the test preparation palonosetron hydrochloride soft capsule (specification: 0.5 mg, license holder: Henan Taifeng Biotechnology Co., Ltd.) and the reference preparation palonosetron hydrochloride in the fasting and postprandial states. Pharmacokinetic characteristics of nosetron soft capsule (Aloxi®, strength: 0.5 mg, licensee: Helsinn Birex Pharmaceuticals Ltd.) in healthy subjects, and evaluation of the bioequivalence of two oral formulations in fasting and postprandial states effectiveness.
Secondary study purpose: To evaluate the test formulation Palonosetron Hydrochloride Soft Capsules (strength: 0.5 mg) and the reference formulation Palonosetron Hydrochloride Soft Capsules (Aloxi®, strength: 0.5 mg) in healthy subjects security.