Bioequivalence evaluation of glibenclamide 5-mg tablets: diabenil® and daonil® (in 24 healthy volunteers).
BACKGROUND
Prescription of generic products is a way to reduce health expense. Bioequivalence is the most appropriate procedure to evaluate the quality and therapeutic efficacy of a generic product. Generic prescriptions are a strategic choice in Tunisia.


OBJECTIVE
We expose in this work, a bioequivalence study witch compare a generic (test) product: DIABENIL* manufactured by a Tunisian pharmaceutical industry Dar Essaidaly to the innovative (reference) product: DAONIL* of Aventis pharma laboratories.


METHODS
The bioequivalence of two glibenclamide 5-mg tablets was determined in healthy human, adult volunteers after a single dose in a randomized cross-over in double blind study. Test and reference were administered to twenty-four healthy volunteers of both sexes after overnight fasting. In total, 15 Blood samples were collected before and following the administration of the drug. Serum concentrations of glibenclamide were determined by validated HPLC method. The pharmacokinetic parameters AUC0t, AUC0 , Cmax and tmax were tested for bioequivalence.


RESULTS
All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of 0.80-1.25 limits.


CONCLUSIONS
We conclude that the two formulations exhibited comparable pharmacokinetic profiles and that the two products can be considered interchangeable in medical practice.
Hanen
H
Ghozzi
Serria
S
Hammami
Hanen
H
Affes
Kamilia
K
Ksouda
Zouheir
Z
Sahnoun
Ahmed
A
Hakim
Mohamed
M
Abid
D000328:Adult; D019540:Area Under Curve; D004311:Double-Blind Method; D005260:Female; D005905:Glyburide / Q000008:administration & dosage / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
D013607:Tablets; D005905:Glyburide