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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the hand. |
|
| 2 | Active Comparator | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the chest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitroglycerin 0.9 % (MXQ-503) | Drug | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement and comparison of the levels of nitroglycerin and its dinitrate 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. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Observation for any adverse events such as headache. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles River Clinical Services | Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Nitroglycerin ointment 2%, USP | Drug | MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |