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Related Experiment Videos

Comparative bioavailability study of two ketoconazole tablet preparations.

K H Yuen1, J W Wong, N Billa

  • 1School of Pharmaceutical Sciences, University of Science Malaysia, Penang.

The Medical Journal of Malaysia
|November 10, 2000
PubMed
Summary

This study found that the generic ketoconazole preparation Zorinax is bioequivalent to the innovator product Nizoral. Both products demonstrated comparable absorption rates and pharmacokinetic profiles in healthy volunteers.

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Area of Science:

  • Pharmacokinetics
  • Pharmaceutical Sciences
  • Clinical Pharmacology

Background:

  • Ketoconazole is an antifungal medication.
  • Generic drug products must demonstrate bioequivalence to innovator products.
  • Evaluating the bioavailability of generic formulations is crucial for therapeutic interchange.

Purpose of the Study:

  • To compare the bioavailability of a generic ketoconazole preparation (Zorinax) with its innovator product (Nizoral).
  • To assess the pharmacokinetic equivalence between Zorinax and Nizoral in healthy male volunteers.

Main Methods:

  • A two-way crossover study design was employed.
  • Eighteen healthy male volunteers participated in the study.
  • Key pharmacokinetic parameters including area under the curve (AUC), peak plasma concentration (Cmax), and time to peak concentration (Tmax) were analyzed.

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Main Results:

  • No statistically significant differences were observed in AUC0-infinity, Cmax, or Tmax between Zorinax and Nizoral.
  • The 90% confidence intervals for the ratios of AUC0-infinity and Cmax were within the acceptable bioequivalence range (0.80-1.25).
  • Elimination rate constant (ke) and apparent volume of distribution (Vd) were comparable between the two ketoconazole formulations.

Conclusions:

  • The generic ketoconazole preparation Zorinax is bioequivalent to the innovator product Nizoral.
  • Zorinax exhibits comparable rate and extent of absorption to Nizoral.
  • The findings support the therapeutic interchangeability of Zorinax and Nizoral.