MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
NCT ID: NCT00513994
Last Updated: 2008-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2007-08-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CROSSOVER
TREATMENT
NONE
Study Groups
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1
Nitroglycerin
MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Interventions
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Nitroglycerin
MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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MediQuest Therapeutics
INDUSTRY
Principal Investigators
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Adel Nada, M.D.
Role: PRINCIPAL_INVESTIGATOR
Charles River Clinical Research
Locations
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Charles River Clinical Services
Tacoma, Washington, United States
Countries
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Other Identifiers
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07-002
Identifier Type: -
Identifier Source: org_study_id