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

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00841594
First received: February 9, 2009
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841594

Locations
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.
ClinicalTrials.gov 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:
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014