[Translation] A single-center, single-dose, two-formulation, two-period, randomized, open-label, double-crossover bioequivalence clinical trial of posaconazole enteric-coated tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹和餐后状态下,单次口服受试制剂T泊沙康唑肠溶片(规格:100mg,北京金城泰尔制药有限公司)与参比制剂R泊沙康唑肠溶片(商品名:诺科飞®,规格:100mg,持证商:Merck Sharp & Dohme Ltd;生产商:N.V.Organon)在健康受试者体内的药代动力学行为,评估受试制剂与参比制剂生物等效性。
次要目的:评价泊沙康唑肠溶片受试制剂T和参比制剂R在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic behavior of the test formulation T posaconazole enteric-coated tablets (specification: 100 mg, Beijing Jincheng Taier Pharmaceutical Co., Ltd.) and the reference formulation R posaconazole enteric-coated tablets (trade name: Nocofil®, specification: 100 mg, licensee: Merck Sharp & Dohme Ltd; manufacturer: N.V. Organon) in healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the test formulation and the reference formulation.
Secondary objective: To evaluate the safety of the test formulation T and the reference formulation R of posaconazole enteric-coated tablets in healthy subjects.