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Volume 8, Issue 6 (Suppl) J Bioequiv Availab
ISSN: 0975-0851 JBB, an open access journal
Page 45
Notes:
Biopharma 2016
September 14-16, 2016
conferenceseries.com
September 14-16, 2016 San Antonio, USA
2nd International Conference & Expo on
Biopharmaceutics and Biologic Drugs
Comparative bioequivalence study of two Rivaroxaban formulations in Iranian healthy volunteers
Mohammad-Reza Rouini1, Adel Haghighi2, Maryam Dibaei1, Ali Akbar Golabchifar1, Kourosh Sadeghi 1 and Nader Pourghasem 3
1Tehran University of Medical Sciences, Iran
2Islamic Azad University, Iran
3Veterinary Organization, Iran
It is a factor Xa inhibitor whose potent anticoagulant and antithrombotic effects have been demonstrated. This study was designed
to evaluate the pharmacokinetics of a new generic formulation of rivaroxaban compared with a brand in healthy Iranian volunteers.
Twenty-eight healthy volunteers enrolled in this study. This study employed a randomized, single-dose, two-way crossover method
using oral tablets of either Axabin® or Xarelto®, as the test drug and reference drug, respectively. Two tablets (2×10 mg) were
administered with 240 ml water. Blood samples were gathered at the following times: 0 hour (predose), and 0.5, 1, 1.5, 2, 2.5, 3, 4,
5, 6, 8, 10, 24, and 30 hours after drug administration. To provide an accurate analysis, rivaroxaban plasma concentrations were
determined by an UHPLC-MS/MS. The optimum separation was performed with a C18 column using acetonitrile and 10mM
ammonium acetate (pH = 3, 70:30, v/v) as a mobile phase, at a flow rate of 0.3 ml/min. Precipitation of proteins was employed for
extraction of rivaroxaban from the plasma samples. The quantification range for rivaroxaban was 2.5–600 -1. According to FDA
guidelines, the bioequivalence assessment’s acceptable range is 80–125% at a 90% confidence interval (CI) for the mean ratios of test/
reference formulation of the pharmacokinetic parameters. The 90% CI of parameters were AUC0-30 (82.02–98.31), AUC0-inf (82.4-
100.34), and Cmax (82.7–104.49). Therefore, the results proved the claim that the two formulations of rivaroxaban are bioequivalent.
Biography
Mohammad-Reza Rouini has completed his PhD from Tehran University of Medical Sciences and Post-doctoral studies from Ottawa University. He is the Director
of Biopharmaceutics Lab at Faculty of Pharmacy. He has published more than 100 papers in reputed journals and has been serving as an Editorial Board Member
of DARU.
Mohammad-Reza Rouini et al., J Bioequiv Availab 2016, 8:6 (Suppl)