The bioequivalence of a new amitriptyline tablet formulation in comparison with a reference preparation |
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Authors: | JE Metzner D Buchberger C Dilger J L?uter U Schmidt |
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Affiliation: | Galmed GmbH, Gesellschaft für galenische und medizinische Forschung, Halle/Saale. |
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Abstract: | 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. |
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