Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants
Status:
Completed
Trial end date:
2019-12-17
Target enrollment:
Participant gender:
Summary
This is a single center, open-label, randomized, single-dose, three-period cross-over study
in healthy participants. The aim of this study is to provide clinically relevant information
on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan
(AMB) tablet, which is intended for pediatric use. The study will compare the relative
bioavailability of the lower dose tablet, dispersed in water and administered orally, with
the reference marketed AMB tablet in healthy adults. The total study duration for each
participant is expected to be approximately 9 weeks.