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


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.


CONCLUSIONS
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.
Pistos
C
C
Independent Research and Laboratory Solutions, Athens, Greece. cpistos@ilsgr.com
Astraka
C
C
Kalovidouris
M
M
Vassilopoulos
E
E
Koutsopoulou
M
M
D000284:Administration, Oral; D000328:Adult; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride