[Translation] Randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle bioequivalence trial of dextromethorphan hydrobromide film in healthy subjects in healthy subjects
预试验主要目的:健康受试者空腹/餐后状态下,口服单剂量儿童氢溴酸右美沙芬膜(受试制剂T,康芝药业股份有限公司生产,规格:3.75mg)与氢溴酸右美沙芬散(参比制剂R,日本盐野义制药株式会社生产,商品名:Medicon®,规格:100mg/g)后,考察空腹和餐后条件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和个体内变异系数,验证血中药物浓度分析方法、采血时间、清洗期时间间隔等设置的合理性。
正式试验主要目的:健康受试者空腹/餐后状态下,口服单剂量儿童氢溴酸右美沙芬膜(受试制剂T,康芝药业股份有限公司生产,规格:3.75mg)与氢溴酸右美沙芬散(参比制剂R,日本盐野义制药株式会社生产,商品名:Medicon®,规格:100mg/g)后,考察空腹/餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂儿童氢溴酸右美沙芬膜和参比制剂氢溴酸右美沙芬散(Medicon®)在健康受试者中的安全性。
[Translation] The main purpose of the pre-test: Healthy subjects take orally a single dose of children's dextromethorphan hydrobromide film (test preparation T, produced by Kangzhi Pharmaceutical Co., Ltd., specification: 3.75mg) and hydrobromide in the fasting/postprandial state. After taking dextromethorphan powder (reference preparation R, produced by Shionogi Pharmaceutical Co., Ltd., Japan, trade name: Medicon®, specification: 100 mg/g), the health status of the test preparation and the reference preparation under fasting and postprandial conditions was examined. The pharmacokinetic parameters and intra-individual variation coefficients in the subjects were used to verify the rationality of the blood drug concentration analysis method, blood collection time, washout interval and other settings.
The main purpose of the formal trial: Oral administration of a single dose of children's dextromethorphan hydrobromide membrane (test preparation T, produced by Kangzhi Pharmaceutical Co., Ltd., specifications: 3.75 mg) and hydrobromide to healthy subjects in the fasting/postprandial state After taking dextromethorphan powder (reference preparation R, produced by Shionogi Pharmaceutical Co., Ltd., Japan, trade name: Medicon®, specification: 100 mg/g), the absorption of the test preparation and the reference preparation under fasting/postprandial conditions was examined. The speed and degree of absorption are used to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To observe the safety of the test preparation children's dextromethorphan hydrobromide membrane and the reference preparation dextromethorphan hydrobromide powder (Medicon®) in healthy subjects.