MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison

May 13, 2011 updated by: MediQuest Therapeutics

MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects

The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

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
    • Washington
      • Tacoma, Washington, United States, 98418
        • Charles River Clinical 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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 50 years of age
  • Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
  • Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.

Exclusion Criteria:

  • Subjects who can not safely discontinue current prescription medications.
  • Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
  • Subjects with an unstable medical problem.
  • Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
  • Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
  • Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
  • Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
  • Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
  • Pregnant or nursing women.
  • Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Applied to the hand.
Drug: nitroglycerin 0.9 % (MXQ-503)
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Active Comparator: 2

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Applied to the chest.
Drug: Nitroglycerin ointment 2%, USP
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Observation for any adverse events such as headache.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

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

Sponsor

MediQuest Therapeutics

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

February 1, 2009

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-001

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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