MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.

Official Title
-----------------
MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Nitroglycerin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers 18 - 70 years of age. Subjects able to give written informed consent and comply with study requirements. Subjects willing and able to safely discontinue all current prescription therapies. Subjects who will agree not to participate in other clinical trials. Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study. Exclusion Criteria: Persons who would be put at risk by discontinuing prescription therapies. Subjects with a known allergy to nitroglycerin. Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol. Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension. Subjects who have participated in a study of an investigational drug within two weeks of visit 1. Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator. Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1. Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied. Pregnant or nursing women. Women of childbearing potential who are unwilling to comply with the contraceptive requirements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Nitroglycerin<br>* MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP<br>* Other names: MQX-503, Nitro-Bid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is the measurement and comparison of the levels of nitroglycerin and its 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. |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary objective is the observation of the volunteers for any adverse events |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Nitroglycerin, pharmacokinetics study of nitroglycerin containing treatments