Bioequivalence Assessment of Sitagliptin/Metformin Extended-Release Fixed-Dose Combinations in Healthy Mexican Subjects Under Fasting and Fed Conditions

Background/Objectives: Management of Type 2 Diabetes (T2D) frequently requires combination therapy. Fixed-dose combinations (FDCs) of sitagliptin and extended-release (ER) metformin improve therapeutic adherence but pose biopharmaceutical challenges related to matrix robustness and food–drug interactions. This study evaluated the pharmacokinetics and bioequivalence of two generic sitagliptin/metformin ER FDCs (50/1000 mg and 100/1000 mg) versus reference products under fasting and fed conditions in healthy Mexican subjects.