【喜報】凱威制藥代工生產(chǎn)的米諾環(huán)素緩釋片在加拿大完成BE試驗
由浙江美華鼎昌醫(yī)藥科技有限公司開發(fā)，委托河北凱威制藥康領分廠生產(chǎn)的鹽酸米諾環(huán)素緩釋片日前在加拿大臨床實驗公司SyneosHealth 公司完成生物等效實驗。實驗數(shù)據(jù)表明鹽酸米諾環(huán)素緩釋片（115mg）和原研美國公司MEDICISPHARMA-CEUTICAL CORP生產(chǎn)的SOLODYN(115mg)的生物等效一致性符合FDA要求。一次性正式通過生物等效臨床實驗。生物等效具體數(shù)據(jù)如下：
For study 180249 (fasting), thebioequivalence criteria are met: for this FDA study, the 90% confidenceintervals must be within 80.00% to 125.00% meaning that the values presentedbelow must be within 80.00% to 125.00% for the AUC0-t, AUC0-inf, and Cmax.
The Summary of PK results for study(Project 180249)
Forstudy 180250 （fed）,the bioequivalence criteria are met: for this FDA study, the 90% confidenceintervals must be within 80.00% to 125.00% meaning that the values presentedbelow must be within80.00% to 125.00% for the AUC0-t, AUC0-inf, and Cmax.
Based on the results,thebioequivalence was concluded as evidenced by the lower and upper CI obtainedwhen the Test Minocycline Hydrochloride is administered compared to theReference Solodyn.
TheSummary of PK results for study (Project 180250).
雙方將于年內提交美國ANDA申請，我司康領分廠口服制劑、原料藥生產(chǎn)體系亦將于近期接受FDA正式檢查。
凱威制藥致力于小容量注射劑和貴細原料藥、口服制劑CMO委托生產(chǎn)，可支持中美雙報、中歐雙報。過去兩年公司已與國內八家企業(yè)達成合作，并啟動了與印度兩家知名仿制藥企的委托加工項目前期調研。
期待與國內外企業(yè)展開更多項目的合作洽談！！
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