MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
This study has been completed.
Sponsor:
MediQuest Therapeutics
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00513994
First received: August 7, 2007
Last updated: April 8, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Nitroglycerin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects |
Resource links provided by NLM:
Further study details as provided by MediQuest Therapeutics:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- A secondary objective is the observation of the volunteers for any adverse events [ Time Frame: 2 weeks ]
| Estimated Enrollment: | 6 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Nitroglycerin
MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Other Name: MQX-503, Nitro-Bid
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513994
Locations
| United States, Washington | |
| Charles River Clinical Services | |
| Tacoma, Washington, United States, 98418 | |
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
| Principal Investigator: | Adel Nada, M.D. | Charles River Clinical Research |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00513994 History of Changes |
| Other Study ID Numbers: | 07-002 |
| Study First Received: | August 7, 2007 |
| Last Updated: | April 8, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MediQuest Therapeutics:
|
Pharmacokinetics Nitroglycerin pharmacokinetics study of nitroglycerin containing treatments |
Additional relevant MeSH terms:
|
Nitroglycerin Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013