Clinical Trial Details
| Trial ID: | L1329 |
| Source ID: | NCT01724788 |
| Associated Drug: | Furosemide |
| Title: | Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Renal Failure |
| Interventions: | DRUG: FUROSEMIDE|DRUG: FUROSEMIDE (HOE058) |
| Outcome Measures: | Primary: Absolute bioavailability (F) of a single 500-mg oral tablet, Day 1, 4, 8, 11 | Secondary: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration, Day 1, 4, 8, 11|To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration, Day 1, 4, 8, 11|To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h), Day 1, 4, 8, 11|To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine, 0, 6, 12, 24 h |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 12 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-11 |
| Completion Date: | 2013-01 |
| Results First Posted: | |
| Last Update Posted: | 2013-02-12 |
| Locations: | Investigational Site Number 124002, Montreal, H1T 2M4, Canada |
| URL: | https://clinicaltrials.gov/show/NCT01724788 |
