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Comparative bioavailability of two immediate release tablets of cisapride in healthy volunteers.

Abstract：

: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 tablets. 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-infinity=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-infinity=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.

journal_name

Eur J Drug Metab Pharmacokinet

journal_title

European journal of drug metabolism and pharmacokinetics

authors

Maya MT,Domingos CR,Guerreiro MT,Filipe AP,Morais JA

doi

10.1007/BF03192297

subject

Has Abstract

pub_date

1998-07-01 00:00:00

pages

377-81

issue

3

eissn

0378-7966

issn

2107-0180

journal_volume

23

pub_type

临床试验,杂志文章,随机对照试验

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