[Testing of bioequivalence of a new sotalol hydrochloride preparation in comparison to a standard formulation]

Author(s): Herrmann R, Kleinbloesem CH

Affiliation(s): Dr. Rentschler Arzneimittel GmbH & Co, Abteilung Qualitatssicherung/Biopharmazie, Laupheim.

Publication date & source: 1995-08, Arzneimittelforschung., 45(8):849-52.

Publication type: Clinical Trial; Comparative Study ; Controlled Clinical Trial; English Abstract; Randomized Controlled Trial

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.