title: [Testing of bioequivalence of a new sotalol hydrochloride preparation in comparison to a standard formulation].
abstract: An investigation on the bioavailability of a new tablet with 160 mg sotalol hydrochloride (CAS 959-24-0, Rentibloc 160), was performed in a two-way cross-over study with 16 volunteers. The relative bioavailability with respect to a reference preparation for AUC0-infinity was 98.1% and for Cmax 100.8%. 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.
authors.affiliation: Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Qualitätssicherung/Biopharmazie, Laupheim.
authors.forename: R
authors.initials: R
authors.lastname: Herrmann
authors.forename: C H
authors.initials: CH
authors.lastname: Kleinbloesem
mesh_terms: D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D013015:Sotalol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
chemical_list: D013015:Sotalol
vernacular_title: Nachweis der Bioäquivalenz einer neuen Sotalolhydrochlorid-Zubereitung im Vergleich zu einer Standardformulierung.