[Testing of bioequivalence of a new sotalol hydrochloride preparation in comparison to a standard formulation].
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.
Herrmann
R
R
Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Qualitätssicherung/Biopharmazie, Laupheim.
Kleinbloesem
C H
CH
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
D013015:Sotalol
Nachweis der Bioäquivalenz einer neuen Sotalolhydrochlorid-Zubereitung im Vergleich zu einer Standardformulierung.