|Objective: the aim of this study was to assess the bioequivalence between two different formulations of daclatasivir 60 mg film coated tablets through pharmacokinetics comparison.
Method: this study was an open label, randomized, fasting, single dose, two-treatment, two-sequence, and two-period crossover study with a one week washout interval between dosing, Dosing of the formulations (test product Levera & reference product Clatazev®) was randomized, then blood samples were collected over 72 hours for pharmacokinetic analysis. A validated high performance liquid chromatography- tandem mass spectrometric method was used to measure daclatasivir concentration in plasma. Cmax, AUC0-t and AUC0-∞ were calculated and were compared to assess bioequivalence
Results: The 90% confidence interval (geometric mean ratios) were 108.32 (98.36-119.29), 111.31 (102.33-121.08) and 110.94 (102.73, 119.78) for Cmax, AUC0-t and AUC0-∞ respectively.
Conclusion: The two formulations are bioequivalent according to regulatory guidelines for bioequivalence assessment; the confidence interval is within the allowable ranges for bioequivalence declaration.
Subscribe now to GaBI Journal to view full information of this article to be published in the next journal issue.