NCT01587313

A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers

A Four-arm, Single Dose, Two-Period, Pharmacokinetic Study of BiDil SR and IR Capsules and Commercial BiDil Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, two-period study. There will be nine healthy human volunteers arbitrarily assigned to one of four groups. The study objective is to compare the action of various combinations of BiDil extended-release capsules and commercial BiDil Tablets in the body over a period of time.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Isosorbide dinitrate / hydralazine capsules	Group 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-04-30
• Last updated: 2015-08-06

Locations

1 site across 1 country: United States