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The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CoFactor |
|
| 2 | Experimental | CoFactor |
|
| 3 | Active Comparator | Leucovorin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoFactor | Drug |
|
| |
| Leucovorin |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of CoFactor formulations in healthy adult subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the 5,10 methylenetetrahydrofolic acid levels after CoFactor and leucovorin administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, MD | Parexel International - Baltimore CPRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International - Baltimore CPRU | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C032418 | 5,11-methenyltetrahydrohomofolate |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| Drug |
|
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |