Journal: Diabetes Therapy
Article Title: Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin–Metformin Fixed-Dose Combination Compared with the Originator Products
doi: 10.1007/s13300-022-01349-2
Figure Lengend Snippet: Sitagliptin mean plasma concentration over 72 h following a single dose of a 100 mg tablet of the generic test product (black triangle) and the originator reference product (blue circle) under fasted conditions ( N = 29). Test product: Sitagliptin 100 mg film-coated tablet; Reference product: Januvia 100 mg
Article Snippet: The sitagliptin study evaluated the bioequivalence of the generic test product “Sitagliptin 100 mg film coated tablet” (containing sitagliptin hydrochloride) with the commercially available originator reference product Januvia 100 mg tablet, distributed by Merck Sharp & Dohme Ltd., Spain (containing sitagliptin phosphate monohydrate).
Techniques: Concentration Assay