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

Completed · Phase 1

Conditions studied: Raynaud's Phenomenon

In brief

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.

Key facts

Study ID

NCT00841594

Run by

MediQuest Therapeutics

People needed

12

Starts

2009-02-01

Expected to finish

2009-03-01

Last updated by the study team

2011-05-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Charles River Clinical Services — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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