Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
Status:
Unknown status
Trial end date:
2020-04-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to compare the bioavailability of a generic product of
lisinopril with that of a reference product when administered to healthy volunteers under
fasting condition. The test product is BF-Lisinopril Tablet 20mg (HK-63564) manufactured by
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited,
and the reference product is Zestril Tab 20mg (HK-30515). The bioequivalence or
bioinequivalence of the test and reference formulations will be assessed and concluded based
on the plasma pharmacokinetic data of lisinopril, as well as WHO guidelines on registration
requirements to establish interchangeability.