NCT01724788

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

Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation (PRLasix® Special, Tablets 500 mg) in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

* Screening: 7 to 10 days * Treatment period: 14 days (Period 1: 7 days; Period 2: 7 days) * End of study: 7 days after the last dosing, * Total duration from screening per subject: 22 to 25 days.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	FUROSEMIDE	Pharmaceutical form: Solution Route of administration: Intravenous
DRUG	FUROSEMIDE (HOE058)	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-11-12
• Last updated: 2013-02-12

Locations

1 site across 1 country: Canada