[Translation] A randomized, open-label, two-dose, single-dose bioequivalence study of indacaterol mometasone inhalation powder (III) in Chinese healthy subjects under fasting conditions
主要目的:以北京抗创联生物制药技术研究有限公司研发的茚达特罗莫米松吸入粉雾剂(Ⅲ)(规格:150 μg /320 μg)为受试制剂,按生物等效性试验的有关规定,以Novartis Pharma AG 持证的茚达特罗莫米松吸入粉雾剂(Ⅲ)(规格:150 μg /320 μg;商品名:Atectura® Breezhaler®)为参比制剂,对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂茚达特罗莫米松吸入粉雾剂(Ⅲ)和参比制剂茚达特罗莫米松吸入粉雾剂(Ⅲ)(Atectura® Breezhaler®)在健康受试者中的安全性。
[Translation] Main purpose: Indacaterol mometasone inhalation powder (III) (specification: 150 μg / 320 μg) developed by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, indacaterol mometasone inhalation powder (III) (specification: 150 μg / 320 μg; trade name: Atectura® Breezhaler®) certified by Novartis Pharma AG was used as the reference preparation. The absorption rate and degree of absorption in healthy humans were compared to investigate the bioequivalence of the two preparations in humans.
Secondary purpose: To observe the safety of the test preparation indacaterol mometasone inhalation powder (III) and the reference preparation indacaterol mometasone inhalation powder (III) (Atectura® Breezhaler®) in healthy subjects.