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Sponsored by: |
Adventrx Pharmaceuticals |
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Information provided by: | Adventrx Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00663481 |
The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy Adults |
Drug: CoFactor Drug: Leucovorin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Single Dose, Within Subject, 3 Period, Pharmacokinetic Bridging Study of CoFactor Formulations and of Leucovorin Administered Intravenously in Healthy, Adult Subjects. |
Estimated Enrollment: | 15 |
Study Start Date: | April 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CoFactor
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Drug: CoFactor |
2: Experimental
CoFactor
|
Drug: CoFactor |
3: Active Comparator
Leucovorin
|
Drug: Leucovorin |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Parexel International - Baltimore CPRU | |
Baltimore, Maryland, United States, 21225 |
Principal Investigator: | Ronald Goldwater, MD | Parexel International - Baltimore CPRU |
Responsible Party: | ADVENTRX Pharmaceuticals, Inc. ( Jeff Stewart, MBA ) |
Study ID Numbers: | CoFactor 510-20 |
Study First Received: | April 18, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00663481 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CoFactor ANX-510 |
Hydroxyzine Vitamin B Complex Vitamins Leucovorin |
Trace Elements Micronutrients Healthy |
Vitamin B Complex Growth Substances Vitamins Physiological Effects of Drugs |
Leucovorin Micronutrients Pharmacologic Actions |