[Bioequivalence of a new tablet formulation of sotalol hydrochloride in comparison to a standard preparations]
Author(s): Herrmann R, Kleinbloesem CH
Affiliation(s): Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Analytische Entwicklung/Biopharmazie, Laupheim.
Publication date & source: 1994-05, Arzneimittelforschung., 44(5):589-92.
Publication type: Clinical Trial; Comparative Study ; English Abstract; Randomized Controlled Trial
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.
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