A Multicenter, Randomized, Double-blind, Three-arm, Parallel Clinical Endpoint Bioequivalence Study of Monometasone Furoate Nasal Spray in Patients With Seasonal Allergic Rhinitis
Taking the mamsonic acid nasal spray held by Zhejiang Xianxian Pharmaceutical Technology Co., Ltd. as the test agent,Bannicate nose spray (product name: inside: insideSchuro®) is a reference preparation. Among the seasonal allergic rhinitis patients, through comparative clinical end, evaluation.The biological equivalent of the two types of branic acid Miimone pine nose spray agent. Observe the test agent and reference preparation in the season.Safety in patients with sexual allergic rhinitis.
糠酸莫米松鼻喷雾剂在季节性过敏性鼻炎患者中的多中心、随机、双盲、三臂、平行的临床终点生物等效性研究
[Translation] Multicenter, randomized, double-blind, three-arm, parallel clinical endpoint bioequivalence study of mometasone furoate nasal spray in patients with seasonal allergic rhinitis
以浙江仙琚医药科技有限公司持有的糠酸莫米松鼻喷雾剂为受试制剂,以MSD Belgium BVBA/SPRL公司持有的糠酸莫米松鼻喷雾剂(商品名:内舒拿®)为参比制剂,在季节性过敏性鼻炎患者中,通过比较临床终点,评价两种糠酸莫米松鼻喷雾剂的生物等效性。观察受试制剂和参比制剂在季节性过敏性鼻炎患者中的安全性。
[Translation] Take mometasone furoate nasal spray held by Zhejiang Xianju Pharmaceutical Technology Co., Ltd. as the test preparation, and take mometasone furoate nasal spray held by MSD Belgium BVBA/SPRL A reference formulation, to evaluate the bioequivalence of two mometasone furoate nasal sprays by comparing clinical endpoints in patients with seasonal allergic rhinitis. To observe the safety of the test preparation and the reference preparation in patients with seasonal allergic rhinitis.
糠酸莫米松鼻喷雾剂在健康受试者中的单中心、随机、开放、两制剂、两序列、交叉设计的生物等效性临床试验
[Translation] A single-center, randomized, open-label, two-drug, two-sequence, crossover design bioequivalence clinical trial of mometasone furoate nasal spray in healthy subjects
主要目的:以浙江仙琚医药科技有限公司提供的糠酸莫米松鼻喷雾剂(规格:每瓶60揿,每揿含糠酸莫米松50μg,药物浓度为0.05%(g/g))作为受试制剂,以MSD Belgium BVBA/SPRL持有的糠酸莫米松鼻喷雾剂(规格:每瓶60揿,每揿含糠酸莫米松50μg,药物浓度为0.05%(g/g);商品名:Nasonex®/内舒拿®)作为参比制剂,评价受试制剂(T)和参比制剂(R)在空腹条件下给药的生物等效性。
次要目的:考察受试制剂(T)和参比制剂(R)在健康受试者中的安全性。
[Translation] Main purpose: Take mometasone furoate nasal spray provided by Zhejiang Xianju Pharmaceutical Technology Co., Ltd. (specification: 60 presses per bottle, each press contains 50 μg of mometasone furoate, and the drug concentration is 0.05% (g/g)) as the subject The test preparation is mometasone furoate nasal spray held by MSD Belgium BVBA/SPRL (specification: 60 presses per bottle, each press contains 50 μg of mometasone furoate, and the drug concentration is 0.05% (g/g); trade name: Nasonex®/Nesuna®) was used as a reference preparation to evaluate the bioequivalence of the test preparation (T) and the reference preparation (R) under fasting conditions.
Secondary purpose: To investigate the safety of the test preparation (T) and the reference preparation (R) in healthy subjects.
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