Raynaud's Phenomenon
Conditions
Keywords
healthy volunteers
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.
Interventions
DRUGnitroglycerin 0.9 % (MXQ-503)
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
DRUGNitroglycerin ointment 2%, USP
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Sponsors
MediQuest Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Observation for any adverse events such as headache. | 3 weeks |
Countries
United States
Outcome results
None listed