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Bioequivalence of two lithium formulations in healthy volunteers.

Author(s): Guilherme MC, Pereira DG, Galuppo MP, Mendes GD, Donato JL, De Nucci G

Affiliation(s): Galeno Research Unit, St. Campinas, Sao Paulo, Brazil.

Publication date & source: 2006, Arzneimittelforschung., 56(7):524-8.

Publication type: Comparative Study ; Randomized Controlled Trial

OBJECTIVE: The purpose of this study was to compare the maximum exposure and extent of bioavailability of two lithium carbonate (CAS 554-13-2) containing 300 mg tablet formulations (test and reference) for oral administration. METHOD: This bioequivalence study was conducted in a 2-period crossover design with a washout phase of 7 days. Plasma samples were obtained by blood sampling over 72 h in each period. Twenty-four healthy volunteers of both genders participated in the trial. Samples were analyzed by a flame atomic absorption spectrometer. Resulting Li+ concentrations were used for determination of the pharmacokinetic parameters AUC(last), AUC(inf) and C(max). RESULTS: 90 % confidence intervals for AUC(last), AUC(inf) and C(max) were 96.81-107.44%, 98.44-109.54% and 98.60-111.33%, respectively. CONCLUSION: All 90% and 95% confidence intervals were inside the limits defined by the FDA Guidance for Industry (80%-125%) and thus stated that test and reference formulation may be accepted as bioequivalent, with regard to both, maximum exposure and extent of bioavailability.

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