title: Bioequivalence and pharmacodynamics of a modified glibenclamide formulation in healthy volunteers.
abstract: 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.
authors.affiliation: LAB Gesellschaft für Pharmakologische Untersuchungen mbH, Neu-Ulm, Fed. Rep. of Germany.
authors.forename: K H
authors.initials: KH
authors.lastname: Molz
authors.forename: R
authors.initials: R
authors.lastname: Klimmek
authors.forename: C
authors.initials: C
authors.lastname: Dilger
authors.forename: G
authors.initials: G
authors.lastname: Pabst
authors.forename: W
authors.initials: W
authors.lastname: Weber
authors.forename: M
authors.initials: M
authors.lastname: Müller
authors.forename: H
authors.initials: H
authors.lastname: Jaeger
mesh_terms: 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
chemical_list: D001786:Blood Glucose; D005905:Glyburide