[Translation] Bioequivalence study of dextromethorphan hydrobromide tablets in single-center, randomized, open-label, single-dose, two-dose, two-period, two-sequence, double-crossover, fasting/fed states in Chinese healthy subjects
主要研究目的:健康受试者空腹或餐后状态下,单次口服广州白云山光华制药股份有限公司生产的受试制剂氢溴酸右美沙芬片(规格:15mg)或Bayer Hispania, S.L.持证、DELPHARM EVREUX生产的参比制剂氢溴酸右美沙芬片(商品名:Romilar®;规格:15mg),分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study: Healthy subjects were given a single oral administration of the test preparation dextromethorphan hydrobromide tablets (specification: 15mg) produced by Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. or Bayer Hispania, S.L. , the reference preparation dextromethorphan hydrobromide tablets produced by DELPHARM EVREUX (trade name: Romilar®; specification: 15mg), respectively investigated the drug effects of the test preparation and the reference preparation in healthy subjects under fasting or postprandial conditions. Kinetic parameters were used to evaluate the bioequivalence of the two preparations.
Secondary research purpose: To investigate the safety of the test preparation and the reference preparation in healthy subjects.