美华鼎昌从2019年年初启动申报美国FDA ANDA的盐酸米诺环素缓释片的cGMP 放大和生物等效实验。经过将近一年多的努力，日前在加拿大临床实验公司Syneos Health 公司完成生物等效实验。实验数据表明美华鼎昌自主研发的盐酸米诺环素缓释片（115mg）和原研美国公司MEDICIS PHARMACEUTICAL CORP生产的SOLODYN(115 mg)的生物等效一致性符合FDA要求。美华鼎昌米诺环素缓释片制剂一次性正式通过生物等效临床实验，表明公司的研发技术和水平进入国际先进和顶端水平。生物等效具体数据如下：

For study 180249 （fasting）, the bioequivalencecriteria are met: for this FDA study, the 90% confidence intervals must bewithin 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.

The Summary of PKresults 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 bioequivalencecriteria are met: for this FDA study, the 90% confidence intervals must bewithin 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 CIobtained when the Test Minocycline Hydrochloride is administered compared tothe Reference Solodyn.

The Summary of PKresults 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