At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Safety Evaluation of Aminophylline and Ambrisentan When Administered Orally Alone and in Combination to Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Aminophylline, Ambrisentan, and 1 other intervention for High Altitude Pulmonary Hypertension. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with the primary objective of testing the safety and tolerability of combined oral doses of aminophylline and ambrisentan in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline (aminophylline) and ambrisentan when administered alone or in combination. It is hypothesized that the combination of these drugs is generally safe, and that no drug interaction can be observed.
Study Details
Timeline
Interventions
Drug will be administered as a single oral dose of 500mg, followed by a 48h washout period.
Drug will be administered as a single dose of 5mg, followed by a 48h washout period
Drugs will be given as single doses of 500mg (aminophylline) and 5mg (ambrisentan), followed by a 48h washout period