Comparative bioavailability of two immediate release tablets of cisapride in healthy volunteers
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Relative bioavailability of cisapride was investigated after oral administration of a test versus a reference formulation of immediate release tablets of cisapride, both with 10 mg per unit. The study was conducted in a two-way cross-over design, as a single dose open-label randomised trial. The two formulations were administered in two treatment days, separated by a washout period of 6 days, in fasted subjects who received one single oral dose of 20 mg of one study medication of cisapride as two 10 mg tables. Multiple samples were collected over 24 h post-dosing. Plasma samples were assayed for cisapride using a selective and sensitive high-performance liquid chromatography (HPLC) method with UV detection. The pharmacokinetic parameter values (mean±RSD%) of cisapride as the test formulation were: AUC0−∞=329±20.9 ng.h/ml, Cmax=52.8±22.6 ng/ml, tmax=1.26±22.0 h and t1/2=4.08 \+-15 h. Following administration of the reference formulation the values obtained for the same parameters were: AUC0\t-\t8=317\+-19.2 ng.h/ml, Cmax=49.2\+-21.3 ng/ml, tmax=1.38\+-30.1 h and t1/2=4.52\+-24.8 h. These results show that the two cisapride formulations can be considered as bioequivalent, with respect to the above mentioned parameters.
KeywordsCisapride human pharmacokinetics bioavailability
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