Bioequivalence Study of Two Formulations of 60 mg Daclatasivir in Healthy Volunteers

Category: Original Research
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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.

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