Bioequivalence of a prednisolone tablet administered as a single oral dose in healthy male volunteers.

Abstract

A bioequivalence study ofprednisolone as Nisolone (test) tablets versus Delta-Cortef (reference) tablets was conducted. Eighteen healthy male Korean volunteers received both 20 mg formulations of prednisolone in this 2 x 2 crossover study with a 1-week washout period between the doses. Plasma concentrations of prednisolone were monitored over a period of 12 hours after the administration using high-performance liquid chromatography. The AUC (area under the plasma concentration-time curve from time zero to infinity) and AUCt (area under the plasma concentration-time curve from time zero to the last sampling time) were calculated using the trapezoidal rule-extrapolation method. The Cmax (maximum plasma drug concentration) and t(max) (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC, AUCt and Cmax and untransformed t(max). The geometric mean of AUCt was 1,786 ng/ml x h (test medication) and 1,787 ng/ml xh (reference medication). A Cmax of 409 ng/ml and 404 ng/ml was achieved for the test and the reference medication, respectively. Point estimates and 90% confidence intervals for AUCt (parametric) and Cmax (parametric) were 0.989 (0.942 approximately 1.039) and 1.013 (0.934 approximately 1.100), respectively. These results satisfy the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value of t(max) was -0.221 (-0.415 approximately 0.000). The 2 medications of prednisolone examined are bioequivalent and, thus, may be prescribed interchangeably.