Development of an In Vitro-In Vivo Correlation for Sitagliptin and Metformin Prolonged-release Tablet Formulations

摘要

The objective of this study was to establish and validate an in vitro-in vivo correlation (IVIVC). To investigate the safety of a fixed-dose combination (FDC) versus the reference formulations (Januvia® 100 mg Filmtabletten co-administered with Glucophage® SR 1000 mg prolonged-release tablets), a bioequivalence study was conducted in the fasted and fed states, and the data generated were used to establish the correlation.