Romanian Society of Pharmaceutical Sciences
 

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RELATIVE BIOAVAILABILITY OF TWO FORMULATIONS CONTAINING DAPAGLIFLOZIN 10 MG UNDER FED CONDITION IN A RANDOMIZED CROSSOVER STUDY IN HEALTHY CAUCASIAN SUBJECTS

MONICA OROIAN 1,2, DIANA IOANA POP 1,2, ANA-MARIA GHELDIU 3*, SANDEEP BHARDWAJ 2, ADRIANA MARCOVICI 2, ARSHAD KHUROO 4, LAURIAN VLASE 1

1.Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Haţieganu”, Cluj-Napoca, Romania
2.Clinical Pharmacology and Pharmacokinetics Department, Terapia SA – a Sun Pharma Company, Cluj-Napoca, Romania
3.Department of Pharmaceutical Botany, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Haţieganu”, Cluj-Napoca, Romania
4.Clinical Pharmacology and Pharmacokinetics Department, Gurugram, India

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The study aimed to evaluate the bioequivalence of a 10 mg dapagliflozin immediate release tablet, developed by Sun Pharmaceutical Industries, India, with the reference product Farxiga® (AstraZeneca Pharmaceuticals LP, USA). The bioequivalence was assessed on 44 healthy Caucasian subjects under fed condition, of which 33 completed both study periods. The clinical trial was designed as an open label, randomized, single-dose, two-treatment, two-period, two-sequence, crossover study, with a wash-out period of 7 days. During both study periods, blood samples were collected before drug administration and post-dose until 48 hours. Dapagliflozin plasma concentrations were determined by a validated LC-MS/MS method. The non-compartmental method was employed for the pharmacokinetic (PK) analysis of data and ANOVA test was used to evaluate the logarithmically transformed values of Cmax and AUCs. The 90% confidence intervals for the evaluated PK parameters were within the accepted range for bioequivalence (80.00 - 125.00%), therefore the test product is bioequivalent with the reference product, under fed condition.