The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment. Hypothesis: Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.
This is a single-centre, open label, single-dose, pharmacokinetic trial with prucalopride in subjects with varying degrees of renal impairment. Subjects were classified into one of four renal function groups, as defined by a 24-hour creatinine clearance determination (CRCL) obtained within 2 weeks before trial entry. Each subject was administered a single 2mg oral dose of prucalopride. Plasma samples and complete urine collections were obtained from 0 through 120 h (6 days) after dosing to characterize the pharmacokinetics of prucalopride.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
single dose of 2 mg prucalopride
To characterize the Pharmacokinetic profile of prucalopride in subjects with various degrees of renal impairement
Secondary efficacy variables: to evaluate the safety and tolerability of prucalopride in subjects with various degrees of renal impairement
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