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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 7, 2007 | ||||
| Last Updated Date | April 8, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 8 hours ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00513994 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
A secondary objective is the observation of the volunteers for any adverse events [ Time Frame: 2 weeks ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects | ||||
| Official Title ICMJE | MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects | ||||
| Brief 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: Nitroglycerin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 6 | ||||
| Completion Date | October 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00513994 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 07-002 | ||||
| Study Sponsor ICMJE | MediQuest Therapeutics | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | MediQuest Therapeutics | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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