MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT00513994
- Run by
- MediQuest Therapeutics
- People needed
- 6
- Starts
- 2007-08-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2008-04-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Charles River Clinical Services — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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