drugset / Trial / NCT02522208

Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets

NCT02522208

Phase 1 Completed 12 enrolled Arbor Pharmaceuticals, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This study will investigate cardiovascular parameters using echocardiographic and pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a study drug free day.

Timeline

Start
2015-09
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydralazine Small molecule 37.5 mg
Subject Hydralazine Small molecule 75 mg
Subject Isosorbide Dinitrate Other / unclassified 20 mg
Subject Isosorbide Dinitrate Other / unclassified 40 mg

Indications