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Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets.

Author(s): van Os S, Relleke M, Piniella PM

Affiliation(s): Synthon BV, Nijmegen, The Netherlands. sandra.vanos@synthon.nl

Publication date & source: 2007-05, Int J Clin Pharmacol Ther., 45(5):293-9.

Publication type: Randomized Controlled Trial

Risperidone is an atypical anti-psychotic, available in various formulations. OBJECTIVE: The objective of the study was to compare the bioavailability of a generic oral solution of risperidone (Test formulation) and Risperdal tablets (Reference formulation). Both formulations contained 1 mg risperidone per dosing unit. METHODS: The study was carried out in 32 healthy volunteers under fasting conditions. Risperidone and 9-hydroxyrisperidone concentrations in plasma were determined using HPLC/MS/MS. RESULTS: The results show that the 90% confidence intervals for the geometric mean ratios of the solution and the tablet formulations were not within the acceptance range of 80 125% for risperidone, whereas the confidence intervals for 9-hydroxyrisperidone were within the acceptance range of 80 - 125%. CONCLUSION: Bioequivalence between the generic 1 mg/ml risperidone solution and the originator tablet formulation was not proven in this study.

Page last updated: 2007-08-04

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