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

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

Condition(s) targeted: Raynaud's Phenomenon

Intervention: nitroglycerin 0.9 % (MXQ-503) (Drug); Nitroglycerin ointment 2%, USP (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: MediQuest Therapeutics


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.

Clinical Details

Official title: MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects

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

Primary outcome: 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.

Secondary outcome: Observation for any adverse events such as headache.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

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

Starting date: February 2009
Last updated: May 13, 2011

Page last updated: August 23, 2015

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