Effect of Food on the Pharmacokinetics of Gliclazide 60 mg Modified Release Tablet in Healthy Caucasian Volunteers

1. http://www.who.int/news-room/fact-sheets/detail/diabetesSearch in Google Scholar

2. Global Reports on Diabetes, World Health Organization, 2016, ISBN: 978 92 4 156525 7.Search in Google Scholar

3. International Diabetes Federation (IDF) Diabetes Atlas Sixth Edition, 2013, ISBN: 2-930229-85-3.Search in Google Scholar

4. Chen X-W, He Z-X, Zhou Z-W, Yang T, Zhang X, Yang Y-X, Duan W, Zhou S-F. Clinical pharmacology of dipeptidyl peptidase 4 inhibitors indicated for the treatment of type 2 diabetes mellitus. Clin Exp Pharmacol P. 2015;42:999-1024.10.1111/1440-1681.1245526173919Search in Google Scholar

5. Verspohl EJ. Novel pharmacological approaches to the treatment of type 2 diabetes. Pharmacol Rev. 2012;64:188-237.10.1124/pr.110.00331922407617Search in Google Scholar

6. He Z-X, Zhou Z-W, Yang Y, Yang T, Pan S-Y, Qiu J-X, Zhou S-F. Overview of clinically approved oral antidiabetic agents for the treatment of type 2 diabetes mellitus. Clin Exp Pharmacol P. 2015;42:125-38.10.1111/1440-1681.1233225360831Search in Google Scholar

7. Blonde L, San Juan ZT. Fixed-dose combinations for treatment of type 2 diabetes mellitus. Adv Ther. 2012;29(1):1-13.10.1007/s12325-011-0094-122271157Search in Google Scholar

8. Hays NP, Galassetti PR, Coker RH. Prevention and treatment of type 2 diabetes: current role of lifestyle, natural product, and pharmacological interventions. Pharmacol Ther. 2008;118(2):181-91.10.1016/j.pharmthera.2008.02.003244190018423879Search in Google Scholar

9. Donath MY. Targeting inflammation in the treatment of type 2 diabetes: time to start. Nat Rev Drug Discov. 2014 Jun;13(6):465-76.10.1038/nrd427524854413Search in Google Scholar

10. Garber A et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2017 executive summary. Endocr Pract. 2017;23(2):207-38.10.4158/EP161682.CS28095040Search in Google Scholar

11. Sarkar A, Tiwari A, Bhasin PS, Mitra M. Pharmacological and pharmaceutical profile of gliclazide: a review. J Appl Pharm Sci. 2011;01(09):11-9.Search in Google Scholar

12. Alsharidah M, Algeffari M, Abdel-Moneim H, Lutfi MF, Alshelowi H. Effect of combined gliclazide/metformin treatment on oxidative stress, lipid profile, and hepatorenal functions in type 2 diabetic patients. Saudi Pharm J. 2018;26:1-6.10.1016/j.jsps.2017.11.007578382129379326Search in Google Scholar

13. Landman GWD, de Bock GH, van Hateren KJJ, van Dijk PR, Groenier KH, et al. Safety and efficacy of gliclazide as treatment for type 2 diabetes: a systematic review and meta-analysis of randomized trials. PLoS ONE. 2014;9(2):e82880. doi:10.1371/journal.pone.0082880.10.1371/journal.pone.0082880392270424533045Search in Google Scholar

14. Elliot DJ, Suharjono, Lewis BC, et al. Identification of the human cytochromes P450 catalyzing the rate-limiting pathways of gliclazide elimination. Br J Clin Pharmacol. 2007;64(4):450-7.10.1111/j.1365-2125.2007.02943.x204854517517049Search in Google Scholar

15. Todor I, Muntean D, Neag M, et al. The influence of CYP2D6 phenotype on the pharmacokinetic profile of atomoxetine in Caucasian healthy subjects. Acta Medica Marisiensis. 2017;63(2):73-9.10.1515/amma-2017-0023Search in Google Scholar

16. Rojanasthien N, Autsavakitipong T, Kumsorn B, et al. Bioequivalence study of modified-release Gliclazide tablets in healthy volunteers. ISRN Pharmacol. 2012;2012. doi:10.5402/2012/375134.10.5402/2012/375134345828623029622Open DOISearch in Google Scholar

17. Gilroy CA, Luginbuhl KM, Chilkoti A. Controlled release of biologics for the treatment of type 2 diabetes. J Control Release. 2016;240:151-64.10.1016/j.jconrel.2015.12.002488956426655062Search in Google Scholar

18. International Diabetes Federation (IDF) Diabetes Atlas Eight Edition, 2017, ISBN: 978-2-930229-87-4.Search in Google Scholar

19. Pop DI, Oroian M Bhardwaj S, Marcovici A, Khuroo A, Kochhar R, Vlase L. Bioequivalence of two formulations of gliclazide in a randomized crossover study in healthy Caucasian subjects under fasting conditions. Clin Pharm Drug Dev. 2018. doi: 10.1002/cpdd.445.10.1002/cpdd.44529578647Open DOISearch in Google Scholar

20. Guidance for industry. Food-effect Bioavailability and Fed Bioequivalence Studies. 2002. Available at:https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070241.pdfSearch in Google Scholar

21. European Medicines Agency. Guideline on the investigation of drug interactions. 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf.Search in Google Scholar

22. Guidelines for bioavailability and bioequivalence studies. Central Drugs Standard Control Organization, Government of India, New Delhi. 2005. Available at: http://www.cdsco.nic.in/html/BE%20Guidelines%20Draft%20Ver10%20March%2016,%2005.pdfSearch in Google Scholar

23. Grbic S, Parojcic J, Ibric S, Djuric Z. In vitro-In vivo correlation for gliclazide immediate-release tablets based on mechanistic absorption simulation. AAPS Pharm Sci Tech. 2011;12(1):165-71.10.1208/s12249-010-9573-y306638521181508Search in Google Scholar

24. Davis TME, Daly F, Walsh JP, Ilett KF, Beilby JP, Dusci LJ, Barrett PHR. Pharmacokinetics and pharmacodynamics of gliclazide in Caucasians and Australian Aborigines with type 2 diabetes. Br J Clin Pharmacol. 2000;49(3):223-30.10.1046/j.1365-2125.2000.00162.x201492110718777Search in Google Scholar