[Study of the bioequivalence of a new isosorbide dinitrate tablet formulation compared with the standard preparation].
An investigation in the bioequivalence of a new tablet formulation with 5 mg isosorbide dinitrate (CAS 87-33-2, ISDN 5 von ct) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to isosorbide dinitrate was 107.5% and for Cmax 112.5%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to isosorbide dinitrate and the metabolites isosorbide-2-nitrate and isosorbide-5-nitrate, respectively. The difference in tmax showed no clinical relevance. The new formulation was bioequivalent to the reference.
Metzner
J E
JE
galmed GmbH, Gcsellschaft für galenische und medizinische Forschung, Halle/Saale, ct-Arzneimittel, Chemische Tempelhof GmbH, Berlin.
Buchberger
D
D
Häring
N
N
Läuter
J
J
D000328:Adult; D001682:Biological Availability; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*
D013607:Tablets; D014665:Vasodilator Agents; C030398:isosorbide-2-mononitrate; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate