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

February 9, 2009
May 13, 2011
February 2009
February 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00841594 on ClinicalTrials.gov Archive Site
Observation for any adverse events such as headache. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Raynaud's Phenomenon
  • Drug: nitroglycerin 0.9 % (MXQ-503)
    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
  • Drug: Nitroglycerin ointment 2%, USP
    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
  • Active Comparator: 1

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

    Applied to the hand.

    Intervention: Drug: nitroglycerin 0.9 % (MXQ-503)
  • Active Comparator: 2

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

    Applied to the chest.

    Intervention: Drug: Nitroglycerin ointment 2%, USP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841594
08-001
No
Fredrick Dechow, President and CEO, MediQuest Therapeutics, Inc.
MediQuest Therapeutics
Not Provided
Not Provided
MediQuest Therapeutics
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP