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OpenTrials
Completed

NCT Number: NCT00841594

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charles River Clinical Services

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nitroglycerin 0.9 % (MXQ-503)

Drug

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

Nitroglycerin ointment 2%, USP

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Observation for any adverse events such as headache.

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

MediQuest Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2009
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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