Status:
COMPLETED
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Lead Sponsor:
MediQuest Therapeutics
Conditions:
Raynaud's Phenomenon
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00841594
Start Date
February 1 2009
End Date
March 1 2009
Last Update
May 17 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charles River Clinical Services
Tacoma, Washington, United States, 98418