Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin–Metformin Fixed-Dose Combination Compared with the Originator Products

被引:0
作者
Yvonne Schnaars
Sumedh Gaikwad
Ulrike Gottwald-Hostalek
Wolfgang Uhl
Olga Ribot
Kanthikiran V. S. Varanasi
Laura Rodríguez
Javier Torrejón
Luis Gómez
机构
[1] Merck Healthcare KGaA,
[2] Galenicum Health S.L.U.,undefined
[3] Galenicum Health India Pvt. Ltd,undefined
来源
Diabetes Therapy | 2023年 / 14卷
关键词
Bioequivalence; Diabetes; Dipeptidyl peptidase-4 inhibitor; Fixed-dose combination; Metformin; Pharmacokinetics; Single-pill combination; Sitagliptin;
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页码:347 / 362
页数:15
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[1]  
Bailey CJ(2017)Metformin: historical overview Diabetologia 60 1566-1576
[2]  
Davies MJ(2022)Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetologia 67 587-597
[3]  
Aroda VR(2007)Sitagliptin Drugs 29 2632-2637
[4]  
Collins BS(2006)Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes Diabetes Care 63 663-674
[5]  
Lyseng-Williamson KA(2014)Effects of sitagliptin and metformin treatment on incretin hormone and insulin secretory responses to oral and “isoglycemic” intravenous glucose Diabetes 29 2638-2643
[6]  
Aschner P(2006)Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone Diabetes Care 37 699-708
[7]  
Kipnes MS(2012)Sitagliptin/metformin (Janumet) as combination therapy in the treatment of type-2 diabetes mellitus Pharmacy Therapeutics 22 1939-1947
[8]  
Lunceford JK(2006)Tolerability and pharmacokinetics of metformin and the dipeptidyl peptidase-4 inhibitor sitagliptin when co-administered in patients with type 2 diabetes Curr Med Res Opin 6 25-37
[9]  
Vardarli I(2013)Safety and efficacy of sitagliptin–metformin in fixed combination for the treatment of type 2 diabetes mellitus Clin Med Insights: Endocrinol Diabetes 71 349-361
[10]  
Arndt E(2011)Sitagliptin/metformin fixed-dose combination. In patients with type 2 diabetes mellitus Drugs 28 307-313