|
|
在研机构- |
|
在研适应症- |
|
最高研发阶段终止 |
首次获批国家/地区- |
首次获批日期1800-01-20 |
Parallel-Group,Double-Blind,Double-Dummy,Superiority Study of Etoricoxib90mg/ Cyclobenzaprine15mg From Eurofarma Versus Etoricoxib90mg (Arcoxia®) and Cyclobenzaprine15mg (XL - Mitrul®) for Muscle Spasm After Third Molar Extraction in Brazil
Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases. Etoricoxib and cyclobenzaprine hydrochloride are active pharmaceutical ingredients (APIs) already registered in the country as mono-drugs. These products are widely used for the proposed indications, and their safety and efficacy profiles are known in daily clinical practice. Once the absence of a pharmacokinetic interaction between etoricoxib and cyclobenzaprine hydrochloride has been confirmed in relative bioavailability studies, this phase 3 study will be conducted for demonstrating the superiority of the new FDC over etoricoxib 90 mg (Arcoxia®) and cyclobenzaprine hydrochloride 15 mg (XL - Mitrul®) in the treatment of moderate to serious pain associated with muscle spasm. The purpose is to provide a new, effective, and safe therapeutic option to address these cases.
100 项与 ADRA2 x H1 receptor x 5-HT2A receptor x COX-2 相关的临床结果
100 项与 ADRA2 x H1 receptor x 5-HT2A receptor x COX-2 相关的转化医学
0 项与 ADRA2 x H1 receptor x 5-HT2A receptor x COX-2 相关的专利(医药)