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

Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Nitroglycerin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: MediQuest Therapeutics

Official(s) and/or principal investigator(s):
Adel Nada, M.D., Principal Investigator, Affiliation: Charles River Clinical Research


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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: A secondary objective is the observation of the volunteers for any adverse events


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


Locations and Contacts

Charles River Clinical Services, Tacoma, Washington 98418, United States
Additional Information

Starting date: August 2007
Last updated: April 8, 2008

Page last updated: August 23, 2015

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