A systematic review on the clinical pharmacokinetics of vildagliptin in healthy and disease populations

References

• Henness S, Keam SJ. Vildagliptin. Drugs. 2006 Oct 01;66(15):1989–2001
   PubMed Web of Science ®Google Scholar
• Mathieu C, Kozlovski P, Paldánius PM, et al. Clinical safety and tolerability of vildagliptin - insights from randomised trials, observational studies and post-marketing surveillance. Eur Endocrinol. 2017 Aug;13(2):68–72. doi: 10.17925/EE.2017.13.02.68
   PubMedGoogle Scholar
• Abdelsalam RM, Safar MM. Neuroprotective effects of vildagliptin in rat rotenone Parkinson’s disease model: role of RAGE‐NF κB and Nrf2‐antioxidant signaling pathways. J Neurochem. 2015;133(5):700–707. doi: 10.1111/jnc.13087
   PubMed Web of Science ®Google Scholar
• Agency EM. Galvus. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/galvus#authorisation-details-section
   Google Scholar
• Xie Y, Zhou Q, He Q, et al. Opportunities and challenges of incretin-based hypoglycemic agents treating type 2 diabetes mellitus from the perspective of physiological disposition. Acta Pharm Sin B. 2022;13(6):2383–2402. doi: 10.1016/j.apsb.2022.11.008
   PubMed Web of Science ®Google Scholar
• Viereck C, Boudes P. An analysis of the impact of FDA’s guidelines for addressing cardiovascular risk of drugs for type 2 diabetes on clinical development. Contemp Clin Trials. 2011;32(3):324–332. doi: 10.1016/j.cct.2011.01.009
   PubMed Web of Science ®Google Scholar
• Foley JE, Jordan J. Weight neutrality with the DPP-4 inhibitor, vildagliptin: mechanistic basis and clinical experience. Vasc Health Risk Manag. 2010;6:541. doi: 10.2147/VHRM.S10952
   PubMedGoogle Scholar
• Ahrén B, Schweizer A, Dejager S, et al. Mechanisms of action of the dipeptidyl peptidase-4 inhibitor vildagliptin in humans. Diab Obes Metab. 2011 Sep;13(9):775–783. doi: 10.1111/j.1463-1326.2011.01414.x
   PubMed Web of Science ®Google Scholar
• Keating GM. Vildagliptin. Drugs. 2010;70(16):2089–2112. doi: 10.2165/11206370-000000000-00000
   PubMed Web of Science ®Google Scholar
• Trevisan R. The role of vildagliptin in the therapy of type 2 diabetic patients with renal dysfunction. Diabetes Ther. 2017 Dec;8(6):1215–1226. doi: 10.1007/s13300-017-0302-3
   PubMed Web of Science ®Google Scholar
• Ito M, Abe M, Okada K, et al. The dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin improves glycemic control in type 2 diabetic patients undergoing hemodialysis. Endocrine J. 2011;58(11):979–987. doi: 10.1507/endocrj.EJ11-0025
   PubMed Web of Science ®Google Scholar
• Haidinger M, Werzowa J, Hecking M, et al. Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation—a randomized, double-blind, placebo-controlled trial. Am J Transplant. 2014;14(1):115–123. doi: 10.1111/ajt.12518
   PubMed Web of Science ®Google Scholar
• Wang J, Wu HY, Chien KL. Cardioprotective effects of dipeptidyl peptidase-4 inhibitors versus sulfonylureas in addition to metformin: a nationwide cohort study of patients with type 2 diabetes. Diabetes metab. 2022 May;48(3):101299. doi: 10.1016/j.diabet.2021.101299
   PubMed Web of Science ®Google Scholar
• Arruda-Junior DF, Salles TA, Martins FL, et al. Unraveling the interplay between dipeptidyl peptidase 4 and the renin-angiotensin system in heart failure. Life Sci. 2022 Sep 15;305:120757.
   PubMed Web of Science ®Google Scholar
• Tang Y-Z, Wang G, Jiang Z-H, et al. Efficacy and safety of vildagliptin, sitagliptin, and linagliptin as add-on therapy in Chinese patients with T2DM inadequately controlled with dual combination of insulin and traditional oral hypoglycemic agent. Diabetol Metab Syndr. 2015;7(1):1–9. doi: 10.1186/s13098-015-0087-3
   PubMedGoogle Scholar
• Sakamoto M, Nishimura R, Irako T, et al. Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): crossover pilot study (J-VICTORIA study). Cardiovasc Diabetol. 2012;11(1):1–7. doi: 10.1186/1475-2840-11-92
   PubMedGoogle Scholar
• Nomoto H, Kimachi K, Miyoshi H, et al. Effects of 50 mg vildagliptin twice daily vs. 50 mg sitagliptin once daily on blood glucose fluctuations evaluated by long-term self-monitoring of blood glucose. Endocrine J. 2017;64(4):417–424. doi: 10.1507/endocrj.EJ16-0546
   PubMed Web of Science ®Google Scholar
• Xiaoyan C, Jing W, Xiaochun H, et al. Effects of vildagliptin versus saxagliptin on daily acute glucose fluctuations in Chinese patients with T2DM inadequately controlled with a combination of metformin and sulfonylurea. Curr Med Res Opin. 2016;32(6):1131–1136. doi: 10.1185/03007995.2016.1162773
   PubMed Web of Science ®Google Scholar
• Panda P. Gliptin therapy in type 2 diabetes in Indian population. J Diabetes Metab . 2015;6(10): 69.
   Google Scholar
• Bari M, Patil AV, Ubhale R, et al. Formulation optimization and Evaluation of push pull osmotic pump tablet of Vildagliptin. Asian J Pharm Technol. 2022;12(3):207–212. doi: 10.52711/2231-5713.2022.00034
   Google Scholar
• He YL. Clinical pharmacokinetics and pharmacodynamics of vildagliptin. Clin Pharmacokinet. 2012 Mar 1;51(3):147–162. doi: 10.2165/11598080-000000000-00000
   PubMed Web of Science ®Google Scholar
• Barghash S, El-Razeq SA, Elmansi H, et al. Intermolecular interactions of saxagliptin and Vildagliptin with human serum albumin. J Appl Spectrosc. 2022;88(6):1266–1275. doi: 10.1007/s10812-022-01308-6
   Web of Science ®Google Scholar
• Yim D-S. Potency and plasma protein binding of drugs in vitro—a potentially misleading pair for predicting in vivo efficacious concentrations in humans. Korean J Physiol Pharmacol. 2019;23(4):231–236. doi: 10.4196/kjpp.2019.23.4.231
   PubMed Web of Science ®Google Scholar
• Asakura M, Karaki F, Fujii H, et al. Vildagliptin and its metabolite M20. 7 induce the expression of S100A8 and S100A9 in human hepatoma HepG2 and leukemia HL-60 cells. Sci Rep. 2016;6(1):35633. doi: 10.1038/srep35633
   PubMedGoogle Scholar
• Polyakova E, Sabirzyanov D, Prozorova N, et al. Physicochemical Properties and Methods of analysis of vildagliptin (review). Pharm Chem J. 2022;56(1):110–117. doi: 10.1007/s11094-022-02606-1
   PubMed Web of Science ®Google Scholar
• Chemical Book. [ cited 2022 11 11]. Available from: https://www.chemicalbook.com/ChemicalProductProperty_EN_CB71449010.htm
   Google Scholar
• Chaphekar MM, Hamrapurkar PD. Development and validation of RP-HPLC assay method for vildagliptin using QbD approach and its application to forced degradation studies. Int J Pharm Sci Drug Res. 2016;8(3):157–165. doi: 10.25004/IJPSDR.2016.080306
   Google Scholar
• Rajam RP, Balaji A, Shanmugam KRA, et al. Formulation and evaluation of vildagliptin beads by emulsion gelation method. Res J Pharm Technol. 2020;13(4):1801–1805. doi: 10.5958/0974-360X.2020.00324.8
   Google Scholar
• Kalpana Patle MB, Rathi J. Formulation and Evaluation of monolithic matrix transdermal therapeutic system of vildagliptin using polymers eudragit RSPO and RLPO. Int J Med Pharm Res. 2018;6(2):50–61.
   Google Scholar
• Arar S, Al-Qudah E, Alzweiri M, et al. New forced degradation products of vildagliptin: identification and structural elucidation using LC-MS, with proposed formation mechanisms. J Liquid Chromatogr Related Technol. 2020 Oct 01;43(15–16):633–644. doi: 10.1080/10826076.2020.1779084
   Web of Science ®Google Scholar
• Abdallah NA, Ahmed AS, Almaghrabi M, et al. Utilization of a TiO2–CuO Bimetallic/Polyaniline Nanocomposite as a transducer in a Solid Contact Potentiometric Sensor for the determination of Vildagliptin. Polymers. 2023;15(19):3991. doi: 10.3390/polym15193991
   PubMed Web of Science ®Google Scholar
• Papp LA, Hancu G, Szabó ZI. Simultaneous determination of enantiomeric and organic impurities of vildagliptin on a cellulose tris(3-chloro-4-methylphenylcarbamate) column under revered-phase conditions. J Pharm Biomed Anal. 2023 Sep 20;234:115495. doi: 10.1016/j.jpba.2023.115495
   PubMed Web of Science ®Google Scholar
• Derar AR, Ahmed N, Hussien EM. A new strategy for the determination of the antidiabetics alogliptin, saxagliptin and vildagliptin using all-solid state potentiometric sensors. BMC Chem. 2023 Jul 16;17(1):79. doi: 10.1186/s13065-023-00988-1
   PubMed Web of Science ®Google Scholar
• Apollo Pharmacy 2022. Available from: https://www.apollopharmacy.in/salt/VILDAGLIPTIN
   Google Scholar
• Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diab Obes Metab. 2011 Jan;13(1):7–18. doi: 10.1111/j.1463-1326.2010.01306.x
   PubMed Web of Science ®Google Scholar
• Lauster CD, McKaveney TP, Muench SV. Vildagliptin: a novel oral therapy for type 2 diabetes mellitus. Am J Health Syst Pharm. 2007;64(12):1265–1273. doi: 10.2146/ajhp060564
   PubMed Web of Science ®Google Scholar
• Novartis Pharma AG B, Switzerland. Galvus Met 2020. Available from: https://www.novartis.com/sg-en/sites/novartis_sg/files/Galvus_Met-Jul2020.SIN-App051120.pdf
   Google Scholar
• Chaplin S, Campbell I. Vildagliptin: alternative add‐on therapy for oral glycaemic control. Prescriber. 2008;19(19):21–27. doi: 10.1002/psb.294
   Google Scholar
• Bekiari E, Rizava C, Athanasiadou E, et al. Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes. Endocrine. 2016 Jun;52(3):458–480. doi: 10.1007/s12020-015-0841-1
   PubMed Web of Science ®Google Scholar
• Monami M, Lamanna C, Desideri CM, et al. DPP-4 inhibitors and lipids: systematic review and meta-analysis. Adv Ther. 2012 Jan;29(1):14–25. doi: 10.1007/s12325-011-0088-z
   PubMed Web of Science ®Google Scholar
• Aroda VR, Henry RR, Han J, et al. Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review. Clin Ther. 2012 Jun;34(6):1247–1258.e22. doi: 10.1016/j.clinthera.2012.04.013
   PubMed Web of Science ®Google Scholar
• Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194–206. doi: 10.1001/jama.298.2.194
   PubMed Web of Science ®Google Scholar
• Atkin SL, Katsiki N, Banach M, et al. Effect of dipeptidyl peptidase-4 inhibitors on circulating tumor necrosis factor-α concentrations: a systematic review and meta-analysis of controlled trials. J Diabetes Complications. 2017 Sep;31(9):1458–1464. doi: 10.1016/j.jdiacomp.2017.05.016
   PubMed Web of Science ®Google Scholar
• Gray LJ, Dales J, Brady EM, et al. Safety and effectiveness of non-insulin glucose-lowering agents in the treatment of people with type 2 diabetes who observe ramadan: a systematic review and meta-analysis. Diab Obes Metab. 2015 Jul;17(7):639–648. doi: 10.1111/dom.12462
   PubMed Web of Science ®Google Scholar
• Sahebkar A, Ponzo V, Bo S. Effect of dipeptidyl peptidase-4 inhibitors on plasma adiponectin: a systematic review and meta-analysis of randomized controlled trials. Curr Med Chem. 2016;23(13):1356–1369. doi: 10.2174/0929867323666160405111354
   PubMed Web of Science ®Google Scholar
• Wu S, Chai S, Yang J, et al. Gastrointestinal adverse events of dipeptidyl peptidase 4 inhibitors in type 2 diabetes: a systematic review and network meta-analysis. Clin Ther. 2017 Sep;39(9):1780–1789.e33. doi: 10.1016/j.clinthera.2017.07.036
   PubMed Web of Science ®Google Scholar
• Craddy P, Palin HJ, Johnson KI. Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison. Diabetes Ther. 2014 Jun;5(1):1–41. doi: 10.1007/s13300-014-0061-3
   PubMed Web of Science ®Google Scholar
• Esposito K, Chiodini P, Maiorino MI, et al. Glycaemic durability with dipeptidyl peptidase-4 inhibitors in type 2 diabetes: a systematic review and meta-analysis of long-term randomised controlled trials. BMJ Open. 2014 Jun 10;4(6):e005442. doi: 10.1136/bmjopen-2014-005442
   PubMed Web of Science ®Google Scholar
• Gooßen K, Gräber S. Longer term safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-analysis. Diab Obes Metab. 2012 Dec;14(12):1061–1072. doi: 10.1111/j.1463-1326.2012.01610.x
   PubMed Web of Science ®Google Scholar
• Richter B, Bandeira-Echtler E, Bergerhoff K, et al. Emerging role of dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes. Vasc Health Risk Manag. 2008;4(4):753–768. doi: 10.2147/VHRM.S1707
   PubMedGoogle Scholar
• Wani JH, John-Kalarickal J, Fonseca VA. Dipeptidyl peptidase-4 as a new target of action for type 2 diabetes mellitus: a systematic review. Cardiol Clin. 2008 Nov;26(4):639–648. doi: 10.1016/j.ccl.2008.06.008
   PubMed Web of Science ®Google Scholar
• Baptista A, Teixeira I, Romano S, et al. The place of DPP-4 inhibitors in the treatment algorithm of diabetes type 2: a systematic review of cost-effectiveness studies. Eur J Health Econ. 2017 Nov;18(8):937–965. doi: 10.1007/s10198-016-0837-7
   PubMed Web of Science ®Google Scholar
• Moher D. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann internal med. 2009;151(4):264–269. doi: 10.7326/0003-4819-151-4-200908180-00135
   PubMed Web of Science ®Google Scholar
• On Biostatistics and Clinical Trials. 2009. Available from: http://onbiostatistics.blogspot.com/2009/03/jadad-scale-to-assess-quality-of.html#:~:text=The%20Jadad%20score%20was%20used,of%20all%20patients%2C%20including%20withdrawals.
   Google Scholar
• Long HA, French DP, Brooks JM. Optimising the value of the critical appraisal skills programme (CASP) tool for quality appraisal in qualitative evidence synthesis. Res Meth Med Health Sci. 2020;1(1):31–42. doi: 10.1177/2632084320947559
   Google Scholar
• Soliman ABE, Pawluk SA, Wilby KJ, et al. The use of a modified Delphi technique to develop a critical appraisal tool for clinical pharmacokinetic studies. Int J Clin Pharm. 2022;44(4):1–10. doi: 10.1007/s11096-022-01390-y
   Web of Science ®Google Scholar
• Higgins JPT, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343(oct18 2):d5928. doi: 10.1136/bmj.d5928
   PubMed Web of Science ®Google Scholar
• He YL, Kulmatycki K, Zhang Y, et al. Pharmacokinetics of vildagliptin in patients with varying degrees of renal impairment. Int J Clin Pharmacol Ther. 2013 Sep;51(9):693–703. doi: 10.5414/CP201885
   PubMed Web of Science ®Google Scholar
• He Y-L, Sabo R, Campestrini J, et al. The influence of hepatic impairment on the pharmacokinetics of the dipeptidyl peptidase IV (DPP-4) inhibitor vildagliptin. Eur J Clin Pharmacol. 2007;63(7):677–686. doi: 10.1007/s00228-007-0312-6
   PubMed Web of Science ®Google Scholar
• He Y-L, Sabo R, Picard F, et al. Study of the pharmacokinetic interaction of vildagliptin and metformin in patients with type 2 diabetes. Curr Med Res Opin. 2009;25(5):1265–1272. doi: 10.1185/03007990902869102
   PubMed Web of Science ®Google Scholar
• He Y-L, Sabo R, Riviere G-J, et al. Effect of the novel oral dipeptidyl peptidase IV inhibitor vildagliptin on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects. Curr Med Res Opin. 2007;23(5):1131–1138. doi: 10.1185/030079907X188008
   PubMed Web of Science ®Google Scholar
• He Y-L, Sadler BM, Sabo R, et al. The absolute oral bioavailability and population-based pharmacokinetic modelling of a novel dipeptidylpeptidase-IV inhibitor, vildagliptin, in healthy volunteers. Clin Pharmacokinet. 2007;46(9):787–802. doi: 10.2165/00003088-200746090-00006
   PubMed Web of Science ®Google Scholar
• He Y-L, Serra D, Wang Y, et al. Pharmacokinetics and pharmacodynamics of vildagliptin in patients with type 2 diabetes mellitus. Clin Pharmacokinet. 2007;46(7):577–588. doi: 10.2165/00003088-200746070-00003
   PubMed Web of Science ®Google Scholar
• He Y, Foteinos G, Neelakantham S, et al. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes Obesity Metab. 2013;15(12):1111–1119. doi: 10.1111/dom.12146
   PubMed Web of Science ®Google Scholar
• He YL, Ligueros‐Saylan M, Sunkara G, et al. Vildagliptin, a novel dipeptidyl peptidase IV inhibitor, has no pharmacokinetic interactions with the antihypertensive agents amlodipine, valsartan, and ramipril in healthy subjects. J Clin Pharmacol. 2008;48(1):85–95. doi: 10.1177/0091270007307880
   PubMed Web of Science ®Google Scholar
• He YL, Sabo R, Campestrini J, et al. The effect of age, gender, and body mass index on the pharmacokinetics and pharmacodynamics of vildagliptin in healthy volunteers. Br J Clin Pharmacol. 2008;65(3):338–346. doi: 10.1111/j.1365-2125.2007.03031.x
   PubMed Web of Science ®Google Scholar
• He YL, Sabo R, Sunkara G, et al. Evaluation of pharmacokinetic interactions between vildagliptin and digoxin in healthy volunteers. J Clin Pharmacol. 2007;47(8):998–1004. doi: 10.1177/0091270007301802
   PubMed Web of Science ®Google Scholar
• He YL, Valencia J, Zhang Y, et al. Hormonal and metabolic effects of morning or evening dosing of the dipeptidyl peptidase IV inhibitor vildagliptin in patients with type 2 diabetes. Br J Clin Pharmacol. 2010 Jul;70(1):34–42. doi: 10.1111/j.1365-2125.2010.03652.x
   PubMed Web of Science ®Google Scholar
• He YL, Wang Y, Bullock JM, et al. Pharmacodynamics of vildagliptin in patients with type 2 diabetes during OGTT. J Clin Pharmacol. 2007 May;47(5):633–641. doi: 10.1177/0091270006299137
   PubMed Web of Science ®Google Scholar
• He Y-L, Zhang Y, Serra D, et al. Thorough QT study of the effects of vildagliptin, a dipeptidyl peptidase IV inhibitor, on cardiac repolarization and conduction in healthy volunteers. Curr Med Res Opin. 2011;27(7):1453–1463. doi: 10.1185/03007995.2011.585395
   PubMed Web of Science ®Google Scholar
• Hu P, Yin Q, Deckert F, et al. Pharmacokinetics and pharmacodynamics of vildagliptin in healthy Chinese volunteers. J Clin Pharmacol. 2009;49(1):39–49.
   PubMed Web of Science ®Google Scholar
• Joshi S, Swain J, Kodgule R, et al. Bioequivalence study of fixed-dose combination of remogliflozin etabonate 100 mg/vildagliptin 50 mg with Individual Components in healthy Indian male subjects under Fed conditions. J Diabetes Treat. 2022;7:10100.
   Google Scholar
• Landersdorfer CB, He YL, Jusko WJ. Mechanism‐based population pharmacokinetic modelling in diabetes: vildagliptin as a tight binding inhibitor and substrate of dipeptidyl peptidase IV. Brit J Clinical Pharma. 2012;73(3):391–401. doi: 10.1111/j.1365-2125.2011.04108.x
   PubMed Web of Science ®Google Scholar
• Mita S, Chitnis SD, Kulmatycki K, et al. Bioequivalence and food effect assessment for vildagliptin/metformin fixed-dose combination tablets relative to free combination of vildagliptin and metformin in Japanese healthy subjects. Int J Clin Pharmacol Ther. 2016;54(4):305. doi: 10.5414/CP202522
   PubMed Web of Science ®Google Scholar
• Pote A, Ravisankar S, Sangle G, et al. Comparative clinical pharmacokinetics and pharmacodynamics of investigational once-daily sustained-release (SR) vildagliptin 100 mg tablet formulation with conventional 50 mg twice-daily regimen in healthy Indian males.
   Google Scholar
• Schnaars Y, Gaikwad S, Gottwald-Hostalek U, et al. Bioequivalence studies of New generic formulations of vildagliptin and fixed-drug combination of vildagliptin and metformin versus respective originator products in healthy volunteers. Diabetes Ther. 2022 Jun;13(6):1215–1229. doi: 10.1007/s13300-022-01269-1
   PubMed Web of Science ®Google Scholar
• Sharma M, Agrawal SS. Bioequivalence study of different brands of vildagliptin in healthy human subjects [journal: article]. Future J Pharm Sci. 2021;7(1). doi: 10.1186/s43094-021-00308-1
   PubMed Web of Science ®Google Scholar
• Sunkara G, Sabo R, Wang Y, et al. Dose proportionality and the effect of food on vildagliptin, a novel dipeptidyl peptidase IV inhibitor, in healthy volunteers. J Clin Pharmacol. 2007 Sep;47(9):1152–1158. doi: 10.1177/0091270007304313
   PubMed Web of Science ®Google Scholar
• Ye L, Li B, Ling N, et al. Pharmacokinetics and Bioequivalence of a generic fixed‐dose combination tablet of metformin hydrochloride/vildagliptin versus a branded product in healthy Chinese subjects under Fed and fasting conditions. Clinical Pharm in Drug Dev. 2022;11(1):63–70. doi: 10.1002/cpdd.992
   PubMed Web of Science ®Google Scholar
• Tatosian DA, Guo Y, Schaeffer AK, et al. Dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes treated with saxagliptin, sitagliptin, or vildagliptin. Diabetes Therapy. 2013;4(2):431–442. doi: 10.1007/s13300-013-0045-8
   PubMed Web of Science ®Google Scholar
• Ayalasomayajula SP, Dole K, He Y-L, et al. Evaluation of the potential for steady-state pharmacokinetic interaction between vildagliptin and simvastatin in healthy subjects. Curr Med Res Opin. 2007;23(12):2913–2920. doi: 10.1185/030079907X233296
   PubMed Web of Science ®Google Scholar
• Breitschaft A, Hu K, Reséndiz KH, et al. Management of hyperglycemia associated with pasireotide (SOM230): healthy volunteer study. Diabetes Res Clin Pract. 2014;103(3):458–465. doi: 10.1016/j.diabres.2013.12.011
   PubMed Web of Science ®Google Scholar
• He H, Tran P, Yin H, et al. Absorption, metabolism, and excretion of [14C] vildagliptin, a novel dipeptidyl peptidase 4 inhibitor, in humans. Drug Metab Dispos. 2009;37(3):536–544. doi: 10.1124/dmd.108.023010
   PubMed Web of Science ®Google Scholar
• He Y-L, Flannery B, Campestrini J, et al. Effect of food on the pharmacokinetics of a vildagliptin/metformin (50/1000 mg) fixed-dose combination tablet in healthy volunteers. Curr Med Res Opin. 2008;24(6):1703–1709. doi: 10.1185/03007990802114070
   PubMed Web of Science ®Google Scholar
• Sangana R, Mittal H, Barsainya S, et al. Therapeutic equivalence of vildagliptin 100 mg once daily modified release to 50 mg twice daily immediate release formulation: an open-label, randomized, two-period, single- and multiple-dose, 6-day crossover study. Diabetes Metab Syndr. 2022;16(3):102438. doi: 10.1016/j.dsx.2022.102438
   PubMed Web of Science ®Google Scholar
• Venkataramanan R, Habucky K, Burckart GJ, et al. Clinical pharmacokinetics in organ transplant patients. Clin Pharmacokinet. 1989 Mar;16(3):134–161. doi: 10.2165/00003088-198916030-00002
   PubMed Web of Science ®Google Scholar
• Shammas FV, Dickstein K. Clinical pharmacokinetics in heart failure. An updated review. Clin Pharmacokinet. 1988 Aug;15(2):94–113. doi: 10.2165/00003088-198815020-00002
   PubMed Web of Science ®Google Scholar
• Benowitz NL, Meister W. Pharmacokinetics in patients with cardiac failure. Clin Pharmacokinet. 1976 Dec 01;1(6):389–405
   PubMed Web of Science ®Google Scholar
• Ogawa R, Stachnik JM, Echizen H. Clinical pharmacokinetics of drugs in patients with heart failure. Clin Pharmacokinet. 2013 Mar 01;52(3):169–185
   PubMed Web of Science ®Google Scholar
• Verma P, Kaur L, Aswal P, et al. Binding interactions of vildagliptin with pepsin: a multi-spectroscopic and in-silico approach and a comparative account with metformin. Spectrochim Acta A Mol Biomol Spectrosc. 2024;304:123368. doi: 10.1016/j.saa.2023.123368
   PubMed Web of Science ®Google Scholar
• Loenen R Low stomach acid: everything you need to know.
   Google Scholar
• Hirtz J. Importance of analytical methods in pharmacokinetic and drug metabolism studies. Biopharm Drug Disp. 1986;7(4):315–326. doi: 10.1002/bdd.2510070402
   PubMed Web of Science ®Google Scholar