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

This study has been completed.
Information provided by:
MediQuest Therapeutics Identifier:
First received: February 9, 2009
Last updated: May 13, 2011
Last verified: May 2011

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.

Condition Intervention Phase
Raynaud's Phenomenon
Drug: nitroglycerin 0.9 % (MXQ-503)
Drug: Nitroglycerin ointment 2%, USP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects

Resource links provided by NLM:

Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Observation for any adverse events such as headache. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00841594

United States, Washington
Charles River Clinical Services
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
MediQuest Therapeutics
  More Information

No publications provided

Responsible Party: Fredrick Dechow, President and CEO, MediQuest Therapeutics, Inc. Identifier: NCT00841594     History of Changes
Other Study ID Numbers: 08-001
Study First Received: February 9, 2009
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:
healthy volunteers

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 15, 2014