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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Charles River Clinical Services, Tacoma, Washington 98418, United States
Additional Information
Starting date: August 2007
Last updated: April 8, 2008
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