Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers
Status:
Completed
Trial end date:
2019-07-03
Target enrollment:
Participant gender:
Summary
The objective of the study is to compare the bioavailability of the Test and Reference
products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and
female volunteers under fed conditions and to assess the bioequivalence of these products
based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as
primary endpoints.