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Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma Canada, Inc. |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00818194 |
The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: extended release tacrolimus Drug: cyclosporine A microemulsion |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Comparison of Effects of Short-Term Low Dose Exposure of Advagraf® and Neoral® Microemulsion Cyclosporine A on Renal Perfusion and Function in Healthy Volunteers |
Enrollment: | 18 |
Study Start Date: | April 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A. tacrolimus first: Experimental
Subjects receive extended release tacrolimus in first dosing interval then cross over to cyclosporine A for second dosing interval
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Drug: extended release tacrolimus
oral
Drug: cyclosporine A microemulsion
oral
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B. cyclosporine first: Experimental
Subjects receive cyclosporine A in first dosing interval then cross over to extended release tacrolimus for second dosing interval
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Drug: extended release tacrolimus
oral
Drug: cyclosporine A microemulsion
oral
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This study seeks to evaluate the renal physiological responses of short-term maintenance level doses of CNIs in healthy volunteers to determine if daily perturbations in renal physiology exist, and if confirmed, whether they differ between CNIs and thus may contribute by different mechanisms to the progression of CAN.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry ) |
Study ID Numbers: | FKC-012, Health Canada Control # 119562 |
Study First Received: | January 6, 2009 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00818194 History of Changes |
Health Authority: | Canada: Health Canada |
Tacrolimus cyclosporine A renal plasma flow glomerular filtration rate |
human pharmacodynamics pharmacokinetics Pharmacodynamics of tacrolimus |
Cyclosporine Immunologic Factors Clotrimazole Miconazole Antifungal Agents Tioconazole |
Tacrolimus Healthy Antirheumatic Agents Immunosuppressive Agents Cyclosporins |
Anti-Infective Agents Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Tacrolimus |
Cyclosporins Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |