Bioequivalence Study of Two Capsule Formulations Containing Diacerein 50 mg in Healthy Human Subjects

Abstract

This study presents the results of a two-way, two-period, two-treatment crossover investigation in 12 healthy Indian male subjects to assess the bioequivalence of two oral formulations containing 50 mg of diacerein (CAS 13739-02-1). Both formulations were administered orally as a single dose separated by a one-week washout period. The content of diacerein in plasma was determined by a validated HPLC method with UV detection. The formulations were compared using the parameters area under the plasma concentration-time curve (AUC_0–t), area under the plasma concentration-time curve from zero to infinity (AUC_0–∞), peak plasma concentration (C_max), and time to reach peak plasma concentration (t_max). The results of this study indicated that there were no statistically significant differences between the logarithmically transformed AUC_0–∞ and C_max values of the two preparations. The 90% confidence interval for the ratio of the logarithmically transformed AUC_0–t, AUC_0–∞ and C_max were within the bioequivalence limit of 0.8–1.25 and the relative bioavailability of the test formulation was 96.63% of that of the reference formulation. Thus, these findings clearly indicate that the two formulations are bioequivalent in terms of rate and extent of drug absorption.

Key words

Antiarthritics - CAS 13739-02-1 - Diacerein, bioequivalence, pharmacokinetics

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