KINETICS OF DAPAGLIFLOZIN 10 MG IMMEDIATE RELEASE TABLET IN HEALTHY CAUCASIAN VOLUNTEERS: DOES FOOD INTAKE AFFECT  ITS DISPOSITION IN THE BODY?

Monica OROIAN; Ana-Maria VLASE; Adriana MARCOVICI; Laurian VLASE

doi:10.24193/subbchem.2023.1.03

KINETICS OF DAPAGLIFLOZIN 10 MG IMMEDIATE RELEASE TABLET IN HEALTHY CAUCASIAN VOLUNTEERS: DOES FOOD INTAKE AFFECT ITS DISPOSITION IN THE BODY?

Authors

Monica OROIAN “Iuliu Hatieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, 8 Victor Babes str., RO-400012, Cluj-Napoca, Romania; Terapia SA – a Sun Pharma Company, Department of Clinical Pharmacology and Pharmacokinetics, 124 Fabricii str., RO-400632, Cluj-Napoca, Romania
Ana-Maria VLASE “Iuliu Hatieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Botany, 23 Marinescu str., RO-400337, Cluj-Napoca, Romania. gheldiu.ana@umfcluj.ro
Adriana MARCOVICI Terapia SA – a Sun Pharma Company, Department of Clinical Pharmacology and Pharmacokinetics, 124 Fabricii str., RO-400632, Cluj-Napoca, Romania
Laurian VLASE “Iuliu Hatieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Technology and Biopharmaceutics, 8 Victor Babes str., RO-400012, Cluj-Napoca, Romania https://orcid.org/0000-0002-0664-3387

DOI:

https://doi.org/10.24193/subbchem.2023.1.03

Keywords:

dapagliflozin, kinetics, Caucasian volunteers, clinical trial, food intake

Abstract

The aim of the current study was to investigate whether food intake alters the kinetics of dapaglliflozin, a modern anti-diabetic agent, after single-dose oral administration of a new 10 mg immediate release tablet. The evaluated formulation was developed and manufactured by Sun Pharmaceutical Industries Limited, India, and the studies were performed in healthy Caucasian subjects. The data obtained during the fasting and fed bioequivalence studies were analyzed to observe the influence of food on the bioavailability and disposition of the evaluated formulation. Although differences were observed between studies concerning some of the main parameters that describe dapagliflozin’s disposition (maximum plasma concentration – C_max, and the time to reach it -T_max), they were proved bioequivalent. The 90% confidence intervals for the evaluated parameters were within the accepted range of 80.00-125.00% for bioequivalence conclusion, therefore the treatments are bioequivalent (dapagliflozin with/without food) and interchangeable. Hence, dapagliflozin can be administered regardless of food intake in diabetic patients.

References

D. Pop; A.-M. Gheldiu; M. Oroian; A. Marcovici; S. Bhardwaj; A. Khuroo; R. Kochhar; L. Vlase; Acta Med Marisiensis, 2018, 64, 161-168.

M.B. Gomes; W. Rathmann; B. Charbonnel; K. Khunti; M. Kosiborod; A. Nicolucci; S.J. Pocock; M.V. Shestakova; I. Shimomura; F. Tang; H. Watada; H. Chen; J. Cid-Ruzafa; P. Fenici; N. Hammar; F. Surmont; L. Ji; Diabetes Res Clin Pract, 2019, 151, 20-32.

A.E. Caballero; Front Endocrinol (Lausanne), 2018, 9, 479.

International Diabetes Federation (IDF) Diabetes Atlas, 10th edition, 2021. Available at: https://diabetesatlas.org/data/en/region/3/eur.html

Global Reports on Diabetes, World Health Organization, 2016, ISBN: 978 92 4 156525 7. Available at: https://www.who.int/publications/i/item/9789241565257

M.A. Abdul-Ghani; R.A. DeFronzo; Expert Opin Pharmacother, 2013, 14, 1695-1703.

M. Isaji; Kidney Int, 2011, 79, S14-S19.

M. Oroian; A. Marcovici; D. Pop; S. Bhardwaj; A. Khuroo; A.-M. Gheldiu; L. Vlase; Studia UBB Chemia, 2019, LXIV, 297-308.

Y. Tamura; H. Miyagawa; T. Yoshida; H. Chuman; Biochim Biophys Acta, 2015, 1848, 2799-2804.

A. Tahara; T. Takasu; M. Yokono; M. Imamura; E. Kurosaki; J Pharmacol Sci, 2016, 130, 159-69.

R.Z.C. de Meira; A.B. Maciel; F.S. Murakami; P.R. de Oliveira; L.S. Bernardi; Int J Anal Chem, 2017, 2017, 2951529.

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

S.C. Chow; Wiley Interdiscip Rev Comput Stat, 2014, 6, 304-312.

A. Mateus; A. Treyer; C. Wegler; M. Karlgren; P. Matsson; P. Artursson; Sci Rep, 2017, 7, 43047.

M. Oroian; D.I. Pop; A.-M. Gheldiu; S. Bhardwaj; A. Marcovici; A. Khuroo; L. Vlase; Acta Med Marisiensis, 2020, 66, 30-34.

M. Oroian; D.I. Pop; A.-M. Gheldiu; S. Bhardwaj; A. Marcovici; A. Khuroo; L. Vlase; Farmacia, 2020, 68, 76-81.

D.I. Pop; A. Marcovici; M. Oroian; A.-M. Gheldiu; L. Vlase; Studia UBB Chemia, 2020, LXV, 187-196.

A.-M. Gheldiu; A. Csavdari; M. Achim; L. Vlase; I. Tomuță; D. Muntean; Studia UBB Chemia, 2017, LXII, 179-188.

A.-M. Gheldiu; D.M. Muntean; I. Cristea; I. Antonescu; R. Chira; C. Ureche; L. Vlase; Rev Chim (Bucharest), 2016, 67, 702-705.

C. Briciu; M. Neag; D. Muntean; L. Vlase; C. Bocsan; A. Buzoianu; A.-M. Gheldiu; M. Achim; A. Popa; J Clin Pharm Ther, 2014, 39, 535–540.

A.-M. Gheldiu; A. Popa; M. Neag; D. Muntean; C. Bocsan; A. Buzoianu; L. Vlase; I. Tomuta; C. Briciu; Pharmacology, 2016, 98, 190-198.

I. Todor; A. Popa; M. Neag; D. Muntean; C. Bocsan; A. Buzoianu; L. Vlase; A.-M. Gheldiu; C. Briciu; J Pharm Pharm Sci, 2016, 19, 198-207.

A.-M. Gheldiu; L. Vlase; A. Popa; C. Briciu; D. Muntean; C. Bocsan; A. Buzoianu; M. Achim; I. Tomuta; I. Todor; D. Leucuta; M. Neag; J Pharm Pharm Sci, 2017, 20, 68-80.

A.-M. Gheldiu; D.M. Muntean; M. Neag; A. Popa; C. Briciu; L. Vlase; Studia UBB Chemia, 2019, LXIV, 153-162.

A.-M. Gheldiu; A. Popa; M. Neag; D. Muntean; C. Bocsan; A. Buzoianu; L. Vlase; M. Achim; I. Todor; C. Briciu; Farmacia, 2015, 63, 453-459.

M. Koziolek; F. Carrière; C.J.H. Porter; Pharm Res, 2018, 35, 55.

P.G. Welling; Annu Rev Nutr, 1996, 16, 383-415.

M. Li; P. Zhao; Y. Pan; C. Wagner; CPT Pharmacometrics Syst Pharmacol, 2018, 7, 82-89.

Y. Kawai; Y. Fujii; F. Tabata; J. Ito; Y. Metsugi; A. Kameda; K. Akimotot; M. Takahashi; Drug Metab Pharmacokinet, 2011, 25, 180-191.

K. Sugano; M. Kataoka; C.C. Mathews; S. Yamashita; Eur J Pharm Sci, 2010, 40, 118-124.

A. Karim; M. Slater; D. Bradford D; L. Schwarts; A. Laurent; J Clin Pharmacol, 2007, 47, 48-55.

D.I. Pop; M. Oroian; S. Bhardwaj; A. Marcovici; A. Khuroo; R. Kochhar; L. Vlase; Clin Pharmacol Drug Dev, 2018, 00, 1-6.

D.I. Pop; M. Oroian; S. Bhardwaj; A. Marcovici; A. Khuroo; R. Kochhar; L. Vlase; Farmacia, 2018, 66, 597-601.

STUDIA UBB CHEMIA, Volume 68 (LXVIII), No. 1, March 2023

Downloads

Published

2023-03-27

How to Cite

OROIAN, M., VLASE, A.-M., MARCOVICI, A., & VLASE, L. (2023). KINETICS OF DAPAGLIFLOZIN 10 MG IMMEDIATE RELEASE TABLET IN HEALTHY CAUCASIAN VOLUNTEERS: DOES FOOD INTAKE AFFECT ITS DISPOSITION IN THE BODY?. Studia Universitatis Babeș-Bolyai Chemia, 68(1), 37–48. https://doi.org/10.24193/subbchem.2023.1.03