[The bioequivalence of a new amitriptyline tablet formulation in comparison with a reference preparation].
An investigation of the bioequivalence of a new tablet formulation (amitriptylin 25 von ct) with 28.3 mg amitriptyline hydrochloride (CAS 549-18-8) was performed in a two-way cross-over study with 18 subjects. The relative bioavailability with respect to a reference preparation for AUC related to amitriptyline (CAS 50-48-6) was 99.3% and for Cmax 100.4%. A positive decision for bioequivalence derived from the usual confidence intervals for both parameters related to amitriptyline and the metabolite nortriptyline (CAS 72-69-5), respectively tmax showed no difference. The new formulation was bioequivalent to the reference.
Metzner
J E
JE
Galmed GmbH, Gesellschaft für galenische und medizinische Forschung, Halle/Saale.
Buchberger
D
D
Dilger
C
C
Läuter
J
J
Schmidt
U
U
D000328:Adult; D000639:Amitriptyline / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000929:Antidepressive Agents, Tricyclic / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001711:Biotransformation; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D009661:Nortriptyline / Q000097:blood / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D000929:Antidepressive Agents, Tricyclic; D000639:Amitriptyline; D009661:Nortriptyline
Untersuchungen zur Bioäquivalenz einer neuen Amitriptylin-Tablettenformulierung im Vergleich zu einer Referenzzubereitung.