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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00318838 |
This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate (GFR) and total creatinine clearance (GFR + active secretion) in healthy subjects. Also, it will assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics (RPF) in healthy subjects.
Condition | Intervention | Phase |
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Healthy |
Drug: Azimilide dihydrochloride Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Assess the Effect of 125 mg/Day Orally Administered Azimilide Dihydrochloride on Renal Function and Hemodynamics in Healthy Volunteers |
Enrollment: | 21 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
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Drug: Placebo
Placebo tablet every 12 hours for 3 days followed by placebo tablet every 24 hours for three days
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2: Experimental
125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
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Drug: Azimilide dihydrochloride
125 mg azimilide tablet every 12 hours for 3 days followed by 125 mg azimilide tablet every 24 hours for three days
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This is a double-blind, parallel-group, placebo-controlled, multiple-dose, single-site study in healthy male and female volunteers. Oral azimilide 125 mg or placebo will be administered every 12 hours for 3 days, followed by 125 mg every 24 hours for 3 days. The study will include a total of 21 healthy subjects (14 active and 7 placebo), all of whom will be confined at the study center for 9 nights.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Parexel CPRU, Harbor Hospital Center | |
Baltimore, Maryland, United States, 21225 |
Study Director: | Jose M Brum, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Jose Brum, MD ) |
Study ID Numbers: | 2006022 |
Study First Received: | April 25, 2006 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00318838 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Calcium Channel Blockers Cardiovascular Agents |
Anti-Arrhythmia Agents Healthy Azimilide |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions Azimilide |