drugset / Trial / NCT01724788

Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

NCT01724788

Phase 1 Completed 12 enrolled Sanofi
RandomizedCrossoverOpen-labelTreatment

Summary

Primary Objective: * To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral formulation in patients with chronic renal failure undergoing peritoneal dialysis. Secondary Objectives: * To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation * To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation

Timeline

Start
2012-11
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 250 mg Intravenous
Subject Furosemide Other / unclassified 500 mg Intravenous

Indications