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Sponsored by: |
Glycadia |
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Information provided by: | Glycadia |
ClinicalTrials.gov Identifier: | NCT00544934 |
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: GLY-230 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects |
Enrollment: | 42 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Laurence Kennedy, M.D. | University of Florida |
Principal Investigator: | Maria del Pilar Solano, M.D. | University of Miami, Miami, Florida |
Principal Investigator: | Lis Cohen, D.O. | Suncoast Clinical Research, New Port Richey, Florida |
Study ID Numbers: | GLY-002 |
Study First Received: | October 15, 2007 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00544934 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Kidney Diseases Diabetes Complications |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus |
Endocrine System Diseases Kidney Diseases Diabetes Complications |