凯威制药生产的米诺环素缓释片在加拿大完成BE试验

由浙江美华鼎昌医药科技有限公司开发,委托河北凯威制药康领分厂生产的盐酸米诺环素缓释片日前在加拿大临床实验公司Syneos Health 公司完成生物等效实验。实验数据表明盐酸米诺环素缓释片(115mg)和原研美国公司MEDICIS PHARMA-CEUTICAL CORP生产的SOLODYN(115 mg)的生物等效一致性符合FDA要求。一次性正式通过生物等效临床实验。生物等效具体数据如下:

        For study 180249 (fasting), the bioequivalence criteria are met: for this FDA study, the 90% confidence intervals must be within 80.00% to 125.00% meaning that the values presented below 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)

PK Parameter

90% Lower CI (%)

90% Upper CI (%)

Ln(AUC0-t)

98.28

116.28

Ln(AUC0-inf)

98.80

112.64

Ln(Cmax)

97.48

110.08

      For study 180250 (fed), the bioequivalence criteria are met: for this FDA study, the 90% confidence intervals must be within 80.00% to 125.00% meaning that the values presented below must be within80.00% to 125.00% for the AUC0-t, AUC0-inf, and Cmax.

       Based on the results,the bioequivalence was concluded as evidenced by the lower and upper CI obtained when the Test Minocycline Hydrochloride is administered compared to the Reference Solodyn.

       The Summary of PK results for study (Project 180250).

PK Parameter

90% Lower CI (%)

90% Upper CI (%)

Ln(AUC0-t)

98.50

105.00

Ln(AUC0-inf)

98.79

105.20

Ln(Cmax)

91.15

103.49

        双方将于年内提交美国ANDA申请, 我司康领分厂口服制剂、原料药生产体系亦将于近期接受FDA正式检查。

       凯威制药致力于小容量注射剂和贵细原料药、口服制剂CMO委托生产,可支持中美双报、中欧双报。过去两年公司已与国内八家企业达成合作,并启动了与印度两家知名仿制药企的委托加工项目前期调研。公司期待与国内外企业展开更多项目的合作洽谈。