Bioequivalence and pharmacodynamics of a modified glibenclamide formulation in healthy volunteers.
A glibenclamide preparation (Glycolande N) with a modified galenic formulation was compared with a marketed standard preparation for bioequivalence and hypoglycaemic action after single oral administration of 3.5 mg. Twelve healthy male volunteers participated in this open two-way cross-over study. The confidence intervals around the mean values of the standard preparation were all in the range of +/- 20%. No significant differences were found between both formulations for Cmax, Tmax, AUC1 and AUC3. The glucose profiles were virtually equal. Both preparations are regarded as bioequivalent and therapeutically equivalent.
Molz
K H
KH
LAB Gesellschaft für Pharmakologische Untersuchungen mbH, Neu-Ulm, Fed. Rep. of Germany.
Klimmek
R
R
Dilger
C
C
Pabst
G
G
Weber
W
W
Müller
M
M
Jaeger
H
H
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D005905:Glyburide / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D006801:Humans; D008297:Male; D012016:Reference Values; D013810:Therapeutic Equivalency
D001786:Blood Glucose; D005905:Glyburide