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Bioequivalence evaluation of two brands of glimepiride 4 mg tablets in healthy subjects.

Author(s): Pistos C, Astraka C, Kalovidouris M, Vassilopoulos E, Koutsopoulou M

Affiliation(s): Independent Research and Laboratory Solutions, Athens, Greece. cpistos@ilsgr.com

Publication date & source: 2005-04, Int J Clin Pharmacol Ther., 43(4):203-8.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: This paper describes a bioequivalence study with two oral glimepiride (4 mg) tablets formulations. The reference preparation was Solosa/Aventis Pharmaceuticals Inc., USA, and the test preparation was Glimepiride/Specifar, Athens, Greece. SUBJECTS, MATERIAL AND METHODS: The study design was open, randomized, two-period, two-sequence, two-treatment with crossover involving 24 healthy male and female subjects. All subjects completed the study. Glimepiride plasma concentrations were measured utilizing a sensitive, reproducible and accurate HPLC method. Pharmacokinetic parameters used to assess bioequivalence were AUC(0_last), AUC(0-inf) for the extent of absorption and Cmax and tmax for the rate of absorption. Statistical evaluation of Cmax, AUC(0_last), and AUC(0-inf) was done after semilogarithmic transformation using a two-way analysis of variance (ANOVA). Tmax values were tested using the distribution-free Hodges-Lehman interval. RESULTS AND CONCLUSION: The parametric 90% confidence intervals for ratio T/R ranged from 90.60-108.00% (point estimate 98.90%) for AUC(0-last), 90.70-107.90% (point estimate 98.90%) for AUC(0-inf) and 86.70-103.70% (point estimate 94.80%) for Cmax, respectively. Based on the results of tmax, Kel and t(1/2), there were no statistically significant differences and the two glimepiride preparations are equivalent with respect to rate and extent of absorption as defined by the European Union bioequivalence requirements.

Page last updated: 2006-01-31

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