[Translation] Bioequivalence trial of montelukast sodium granules in healthy adult subjects in a randomized, open-label, single-dose, two-cycle, two-crossover, fasting/fed state.
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定陕西东科制药有限责任公司研制的孟鲁司特钠颗粒给药后的孟鲁司特在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以 Merck Sharp & DohmeCorp.持证,Patheon
Manufacturing Services LLC 生产的孟鲁司特钠颗粒[商品名:顺尔宁®]为参比,考察受试制剂的相对生物利用度,评价制剂间的生物等效性,并观察孟鲁司特钠颗粒在中国健康受试者中的安全性。
[Translation] Taking Chinese healthy subjects as the test subjects, a self-cross-controlled experimental design was used to measure the blood levels of montelukast in healthy subjects after the administration of Montelukast sodium granules developed by Shaanxi Dongke Pharmaceutical Co., Ltd. The time course of drug concentration, the corresponding pharmacokinetic parameters were estimated, and certified by Merck Sharp & DohmeCorp., Patheon
The montelukast sodium granules [trade name: Singalin®] produced by Manufacturing Services LLC were used as a reference to investigate the relative bioavailability of the test preparations, evaluate the bioequivalence between the preparations, and observe the montelukast sodium. Safety of granules in healthy Chinese subjects.