The relative bioavailability of two formulations containing 10 mg Dapagliflozin assessed under fasting conditions in a randomized crossover study in healthy Caucasian subjects

1. European Medicines Agency, Committee for Medicinal Products for Human Use, Guideline on the investigation of bioequivalence. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf [accessed June 22nd 2019]Search in Google Scholar

2. 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 fed condition. Farmacia 2018; 66(4): 597-601.10.31925/farmacia.2018.4.6Search in Google Scholar

3. U.S. Department of Health and Human Services Food and Drug Administration, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. http://academy.gmp-compliance.org/guidemgr/files/UCM154838.PDF [accessed June 22nd 2019]Search in Google Scholar

4. 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 2019; 8(1): 16-21.10.1002/cpdd.445Search in Google Scholar

5. International Council for Harmonisation, Topic E8 General considerations for clinical trials. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-8-general-considerations-clinical-trials-step-5_en.pdf [accessed June 22nd 2019]Search in Google Scholar

6. Pop DI, Gheldiu AM, Oroian M, Marcovici A, Bhardwaj S, Khuroo A, Kochhar R, Vlase L. Effect of food on the pharmacokinetics of gliclazide 60 mg modified release tablet in healthy Caucasian volunteers. Acta Med Marisiensis 2018; 64(4): 161-168.10.2478/amma-2018-0022Search in Google Scholar

7. International Diabetes Federation, Diabetes Atlas, 8th edition 2017. https://diabetesatlas.org/IDF_Diabetes_Atlas_8e_interactive_EN/ [accessed June 22nd 2019]Search in Google Scholar

8. International Diabetes Federation, Clinical Practice Recommendations for managing Type 2 Diabetes in Primary Care. https://www.idf.org/e-library/guidelines/128-idf-clinical-practice-recommendations-for-managing-type-2-diabetes-in-primary-care.html [accessed June 22nd 2019]Search in Google Scholar

9. Kahn SE, Cooper ME, Del Prato S. Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present and future. Lancet 2014; 383(9922): 1068–1083.10.1016/S0140-6736(13)62154-6Search in Google Scholar

10. McGurnaghan SJ, Brierley L, Caparrotta TM et al. The effect of dapagliflozin on glycaemic control and other cardiovascular disease risk factors in type 2 diabetes mellitus: a real-world observational study. Diabetologia 2019; 62: 621-632.10.1007/s00125-018-4806-930631892Search in Google Scholar

11. Oroian M, Marcovici A, Pop DI, Bhardwaj S, Khuroo A, Gheldiu AM, Vlase L. Kinetics of dapagliflozin after single dose oral administration of a 10 mg immediate release tablet. Studia UBB Chemia 2019; LXIV(2, Tom I): 297-308.Search in Google Scholar

12. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009; 32(4): 650–657.10.2337/dc08-1863266044919114612Search in Google Scholar

13. Henry RR, Rosenstock J, Edelman S et al. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care 2015; 38(3): 412–419.10.2337/dc13-295525271207Search in Google Scholar

14. Ferrannini E, Jimenez Ramos S, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise. Diabetes Care 2010; 33(10): 2217–2224.10.2337/dc10-0612294516320566676Search in Google Scholar

15. U.S. Department of Health and Human Services Food and Drug Administration, Draft Guidance on Dapagliflozin Propanediol. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapagliflozin%20propanediol%20_oral%20tablet_202293_RC06-15.pdf [accessed June 22nd 2019]Search in Google Scholar