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

August 4, 2015 updated by: Arbor Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Frontage Cinical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, nonsmoking, slow acetylator (as determined by caffeine metabolite assay) males or females between the ages of 18 to 40 years inclusive.
  • Body weight at least 150 pounds and Body Mass Index between 18.5 and 30 kg/m2.
  • Medical history, physical examination, and clinical laboratory test results indicating either normal vital organ/endocrine functions, or no clinically significant abnormalities.
  • Clinical laboratory testing negative for: HIV, Hepatitis B surface antigen and Hepatitis C antibody.
  • Urine testing negative for drugs of abuse (including, but not limited to marijuana, amphetamines, barbiturates and cocaine).
  • Negative urine cotinine test and negative saliva alcohol test.
  • Negative urine HCG test, consistent with no pregnancy (females only).
  • For female subjects, a recent history of menses that is regular for the individual (24 36 day cycles).
  • Females participating in this study must be:
  • unable to have children (e.g., post-menopausal, tubal ligation, hysterectomy) OR
  • willing to remain abstinent [not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 14 days after the last dose] OR
  • willing to use two effective barrier methods of birth control (partner using condom and female using IUD, diaphragm plus spermicide, or contraceptive sponge).
  • Ability to grant voluntary informed consent to participate in the study.

Exclusion Criteria:

  • Known history or presence of any clinically significant medical condition.
  • Known or suspected carcinoma.
  • Use of prescription or OTC drug(s), other than acetaminophen, within two weeks of first dose of study drug and throughout study unless approved by the investigator or sponsor.
  • Use of alcohol or caffeine containing products within 48 hours of each dose of study drug.
  • History of, or evidence of clinically significant medical condition, including, but not limited to hepatic, renal, cardiac, vascular, gastrointestinal, or thyroid disease, diabetes, epilepsy, respiratory or hematological disease, acute narrow angle glaucoma or psychiatric disorder which, in the opinion of the Investigator would confound the study results or present a risk to the subject.
  • History of alcohol or drug abuse within one year of study participation.
  • Presence of, or known hypersensitivity, allergy, idiosyncratic reaction or adverse reaction to caffeine, ISDN, hydralazine HCl, or any compounds with similar chemical characteristics.
  • Received an investigational drug within 30 days of the first dose in this study.
  • Blood pressure less than 110/70 mm Hg at screening or at Day 1 prior to dosing.
  • Donated one pint or more of blood or donated platelets within 30 days of the first dose in this study.
  • Any subject who, in the opinion of the Investigator, cannot follow instructions.
  • With regard to females; pregnancy, lactation, or the use of hormonal contraception.
  • History of lupus erythematous or lupus like syndrome.
  • Use of herbal preparations or use of phosphodiesterase inhibitors.
  • Employee of the Sponsor or CRO.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 am
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
Other Names:
  • BiDil tablets; ISDN/HYD
EXPERIMENTAL: Group 2
ISDN/HYD 2 SR caps crossover to 1 IR cap at 5 pm
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
Other Names:
  • BiDil tablets; ISDN/HYD
EXPERIMENTAL: Group 3
ISDN/HYD 2 SR caps crossover to 1 IR cap at 8 pm
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
Other Names:
  • BiDil tablets; ISDN/HYD
ACTIVE_COMPARATOR: Group 4
ISDN/HYD 1 IR cap and two SR caps at 8 am crossover to Day 8: BiDil Tablet tid
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
Other Names:
  • BiDil tablets; ISDN/HYD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma/blood concentration versus time curve, as calculated by the linear trapezoidal method for Hydralazine and ISDN and metabolites.
Time Frame: from time zero (0) to 24 hr
from time zero (0) to 24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbor Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Gregory J Tracey, MD, Frontage Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (ESTIMATE)

April 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR06.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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