[Bioequivalence of a new tablet formulation of sotalol hydrochloride in comparison to a standard preparations].
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.
Herrmann
R
R
Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Analytische Entwicklung/Biopharmazie, Laupheim.
Kleinbloesem
C H
CH
D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D008297:Male; D013015:Sotalol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D013015:Sotalol
Bioäquivalenz einer neuen Tablettenformulierung mit Sotalolhydrochlorid im Vergleich zu einer Standardzubereitung.