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    STUDIA CHEMIA - Issue no. 2, Tom I / 2019  
         
  Article:   KINETICS OF DAPAGLIFLOZIN AFTER SINGLE DOSE ORAL ADMINISTRATION OF A 10 MG IMMEDIATE RELEASE TABLET.

Authors:  MONICA OROIAN, ADRIANA MARCOVICI, DIANA IOANA POP, SANDEEP BHARDWAJ, ARSHAD KHUROO, ANA-MARIA GHELDIU, LAURIAN VLASE. 		 
       
         
  Abstract:  The present study aimed to elucidate and describe the basic pharmacokinetics of dapagliflozin after a single dose oral administration of a 10 mg immediate release tablet developed by Sun Pharmaceutical Industries Limited, India. Ten competing models were created in order to analyze the experimental data obtained from the 71 subjects who were enrolled and finalized two bioequivalence clinical trials, under fasting and fed state. The studies took place at the Clinical Pharmacology and Pharmacokinetics Department of Terapia S.A. Considering the Akaike index value for a rational model discrimination, model number 8 (M8) was found to be the best that fits the experimental data. The representative pharmacokinetic model involves zero order absorption kinetics with a lag time of approximately 0.3 hours, first order systemic metabolism and elimination and two-compartmental distribution. Furthermore, by using M8, the most important pharmacokinetic parameters of dapagliflozin were determined. All calculations were performed by Phoenix WinNonlin® version 6.3 (Certara, USA).

Keywords: dapagliflozin, compartmental pharmacokinetic analysis, subjects, bioequivalence clinical trials 		 
         
     
         
         
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