R108512 SOLUTION IN PEDIATRIC SUBJECTS W/ FUNCTIONAL FECAL RETENTION

在儿科人群中，便秘是约3%的儿科门诊就诊的主要主诉;多达25%的儿科胃肠病学家转诊是便秘儿童。 这些儿童中的大多数患有功能性便秘，称为FFR或功能性粪便潴留。本试验的主要目的是描述在小于/大于4岁至小于/大于12岁的具有血流储备分数的儿科受试者中单次口服0.03 mg/kg普卢卡必利的药代动力学特征。 该剂量相当于成人剂量0.15 - 2.0 mg普卢卡必利。 次要目的是评价对FFR儿科受试者单次口服普卢卡必利溶液（0.03 mg/kg）的安全性和耐受性（不良反应）。 本试验不评价疗效。

In the pediatric population, constipation is the chief complaint in about 3% of all pediatric outpatient visits; as many as 25% of referrals to pediatric gastroenterologists are for children with constipation. The majority of these children have a form of functional constipation, referred to as FFR or functional fecal retention. The primary objective of this trial is to characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in pediatric subjects aged less than/greater than 4 to less than/greater than 12 years with FFR. This dose corresponds to an adult dose of .15 - 2.0 mg of prucalopride. The secondary objective is to evaluate the safety and the tolerability (adverse experiences) of a single oral dose of prucalopride solution, 0.03 mg/kg, given to pediatric subjects with FFR. No efficacy will be evaluated in this trial.