[Translation] A single-center, randomized, open-label, single (fasting/after meal) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence study of Montelukast Sodium Granules in Chinese healthy subjects 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:西安远大德天药业股份有限公司;上市许可持有人:陕西天宇制药有限公司)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 the single oral administration of the test preparation Montelukast Sodium Granules (specification: 0.5g: 4mg (calculated as Montelukast)) to Chinese healthy subjects in the fasting/postprandial state; Manufacturer: Xi'an Yuandade Tian Pharmaceutical Co., Ltd.; Marketing Authorization Holder: Shaanxi Tianyu Pharmaceutical Co., Ltd.) and the reference preparation Montelukast Sodium Granules (trade name: Singulair; Specifications: 0.5g: 4mg (based on Montelukast ); Manufacturer: Patheon Manufacturing Services LLC; Licensee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) to evaluate the pharmacokinetic characteristics of the two preparations in the fasting/postprandial state of bioequivalence.
Secondary purpose: To observe the safety of the test preparation Montelukast Sodium Granules and the reference preparation Montelukast Sodium Granules (Singulair) in Chinese healthy subjects.