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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arbor Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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