[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.
Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Analytische Entwicklung/Biopharmazie, Laupheim.
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Herrmann
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Kleinbloesem
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.