Pharmacokinetics and relative bioavailability of a generic amisulpride tablet in healthy Chinese volunteers

Abstract

The study demonstrated that the two preparations met the regulatory criteria for bioequivalence and both formulations were well tolerated. .

Bioequivalence of 200 mg Amisulpride Tablets in Healthy Chinese Volunteers under Fasting and Fed Conditions

“…In recent years, a variety of generic products prepared in China have been studied for bioavailability equivalence in healthy Chinese volunteers 9–11 . Although some scholars have already studied the pharmacokinetic (PK) characteristics of amisulpride, data collected in the Chinese population are insufficient to draw any conclusions 12,13 . In addition, a survey conducted in India revealed no statistically significant differences between the test and reference drugs, and the 2 formulations were deemed bioequivalent 14 …”