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

NCT01587313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Arbor Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory J Tracey, MD · Frontage Laboratories, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01587313 on ClinicalTrials.gov