[Translation] Human bioequivalence of single-center, randomized, open-label, single (fasting/postprandial) oral administration of montelukast sodium granules in healthy Chinese subjects, two preparations, two sequences, two cycles, and crossover test
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂孟鲁司特钠颗粒(规格:0.5g:4mg(以孟鲁司特计);生产企业:重庆华森制药股份有限公司;持证商:佑华医药科技有限公司)和参比制剂孟鲁司特钠颗粒(商品名:顺尔宁;规格:0.5g:4mg(以孟鲁司特计);生产企业:Patheon Manufacturing Services LLC;持证商:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂孟鲁司特钠颗粒和参比制剂孟鲁司特钠颗粒(顺尔宁)在中国健康受试者中的安全性。
[Translation] Main purpose: To observe Chinese healthy subjects taking a single oral dose of the test preparation montelukast sodium granules (specification: 0.5g: 4mg (calculated as montelukast) in the fasting/postprandial state; manufacturer: Chongqing Huasen Pharmaceutical Co., Ltd.; licensee: Youhua Pharmaceutical Technology Co., Ltd.) and the reference preparation Montelukast sodium granules (trade name: Singulan; Specification: 0.5g: 4mg (calculated as montelukast); production Enterprise: Patheon Manufacturing Services LLC; Licensee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) Pharmacokinetic profile, evaluation of biology of both formulations in fasting/fed state, etc. effectiveness.
Secondary objective: To observe the safety of the test preparation montelukast sodium granules and the reference preparation montelukast sodium granules (Singerning) in healthy Chinese subjects.