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Sponsored by: |
Rovi Pharmaceuticals Laboratories |
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Information provided by: | Rovi Pharmaceuticals Laboratories |
ClinicalTrials.gov Identifier: | NCT00629733 |
Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: RO-14 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Estimated Enrollment: | 12 |
Study Start Date: | December 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Ro-14: Experimental
12 arms
|
Drug: RO-14 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital Santa Creu i Sant Pau ( Dr. Barbanoj ) |
Study ID Numbers: | ROV-RO14-2006-01 |
Study First Received: | February 15, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00629733 |
Health Authority: | Spain: Spanish Agency of Medicines |
pharmacokinetics ultra low molecular weight heparin |
Body Weight Heparin, Low-Molecular-Weight Healthy Heparin Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |