MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
| City: |
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Tacoma |
| State: |
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Washington |
| Zip Code: |
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98418 |
| Conditions: |
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Raynaud's Phenomenon |
| Purpose: |
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The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical
cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 18 to 50 years of age
- Subjects who do not take any prescription medication or who can safely discontinue
use prior to visit 1.
- Negative pregnancy test for fertile women and agree to use effective contaception
throughout the study.
Exclusion Criteria:
- Subjects who can not safely discontinue current prescription medications.
- Subjects who have a known allergy to nitroglycerin or common topical formulation
ingredients.
- Subjects with an unstable medical problem.
- Subjects who, within the past three months, have had either a myocardial infarction,
uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or
uncontrolled hypertension.
- Subjects who participated in a study of any investigational drug or device within
four weeks prior to Visit 1.
- Subjects who have screening laboratory values which are outside the normal range and
which are considered to be clinically significant to the investigator.
- Subjects who have had major abdominal, thoracic, or vascular surgery within six
months of Visit 1.
- Subjects with non-epithelialized skin lesions or interfering skin conditions at time
of screening in the area where either study medication is to be applied.
- Pregnant or nursing women.
- Women of childbearing potential who are unable or unwilling to comply with the
contraceptive requirements during the study period.
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| NCT ID: |
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NCT00841594 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Tacoma, Washington 98418
United States
Robin Downey, M.D.
Phone: 253-779-8815
Email: RecruitersNW@crl.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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