[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of montelukast sodium granules in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover
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] Primary objective: To observe the pharmacokinetic characteristics of the test preparation montelukast sodium granules (specification: 0.5g: 4mg (as montelukast); manufacturer: Chongqing Huasen Pharmaceutical Co., Ltd.; licensee: Youhua Pharmaceutical Technology Co., Ltd.) and the reference preparation montelukast sodium granules (trade name: Singulair; specification: 0.5g: 4mg (as montelukast); manufacturer: Patheon Manufacturing Services LLC; licensee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) after a single oral administration in the fasting/fed state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary objective: To observe the safety of the test preparation montelukast sodium granules and the reference preparation montelukast sodium granules (Singulair) in healthy Chinese subjects.