Dataset from An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension

The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.

本研究旨在证实，针对特发性肺动脉高压（idiopathic pulmonary arterial hypertension, PAH）或家族性肺动脉高压患儿采用儿科制剂给药时，其体内波生坦的暴露水平与PAH成人患者的暴露水平相当；同时评估该波生坦儿科制剂在该患者人群中的耐受性与安全性。