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

2019-09-24 05:27:27 | BioPortfolio


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.

Study Design


Hypertension, Pulmonary


AMB new formulation (1 mg), Reference AMB (5 mg)


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2019-09-24T05:27:27-0400

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Medical and Biotech [MESH] Definitions

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A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

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