Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

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.

Timeline

Start

2019-09-30

Primary completion

2019-12-17

Completion

2019-12-17

Drugs

Indications