Bioequivalence of a new tablet formulation of sotalol hydrochloride in comparison to a standard preparations
Herrmann, R.; Kleinbloesem, C.H.
Arzneimittel-Forschung 44(5): 589-592
1994
ISSN/ISBN: 0004-4172 PMID: 8024627 Document Number: 434869
Bioequivalence of a New Sotalol Hydrochloride Tablet Formulation Compared with a Standard Preparation An investigation on the bioavailability of a new tablet with 80 mg sotalol hydrochloride (Rentibloc mite, CAS 959-24-0) was performed in a two-way cross-over study with 16 persons. The relative bioavailability with respect to a reference preparation for AUC0-infinity was 101.9% and for Cmax 104.5%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters. The difference in tmax showed no clinical relevance. The new formulation is bioequivalent to the reference.