Overview

The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
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 theophylline and bambuterol in healthy human subjects. The secondary objective is to assess the pharmacokinetic profiles of theophylline and bambuterol 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.
Phase:
Phase 1
Details
Lead Sponsor:
Norwegian Armed Forces Medical Service
Collaborators:
Duke University
Oslo University Hospital
Treatments:
Bambuterol
Terbutaline
Theophylline