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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Charles River Clinical Services, Tacoma, Washington 98418, United States
Additional Information
Starting date: February 2009
Last updated: May 13, 2011
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