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

Phase 1

Completed

• Conditions: Renal Failure
• Interventions: Drug: FUROSEMIDE; Drug: FUROSEMIDE (HOE058)

• Registration Number: NCT01724788
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2012-10-30
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Furosemide PO - IV	FUROSEMIDE	Oral furosemide allocated at the beginning of Period 1, then cross-over to IV furosemide (a minimum 7-day diuretic free washout period required between the two periods)
Furosemide PO - IV	FUROSEMIDE (HOE058)	Oral furosemide allocated at the beginning of Period 1, then cross-over to IV furosemide (a minimum 7-day diuretic free washout period required between the two periods)
Furosemide IV - PO	FUROSEMIDE	IV furosemide allocated at the beginning of Period 1, then cross-over to oral furosemide (a minimum 7-day diuretic free washout period required between the two periods)
Furosemide IV - PO	FUROSEMIDE (HOE058)	IV furosemide allocated at the beginning of Period 1, then cross-over to oral furosemide (a minimum 7-day diuretic free washout period required between the two periods)

Primary Outcome Measures

Name	Time	Method
Absolute bioavailability (F) of a single 500-mg oral tablet	Day 1, 4, 8, 11

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site Number 124002; 🇨🇦 Montreal, Canada