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

Primary Purpose

Renal Failure

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

FUROSEMIDE

FUROSEMIDE (HOE058)

About this trial

This is an interventional treatment trial for Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

Male or female, 18 years old or older, with chronic renal failure undergoing peritoneal dialysis for at least 3 months.
Women of childbearing age should have a negative pregnancy test before administration of the study drug

Exclusion criteria:

Contra-indications to furosemide, including:
- Hypersensitivity to furosemide or to sulphonamide-derived drugs or to any ingredient in the formulation or component of the container.
- Glomerular filtration rate below 5 mL/min
- Glomerular filtration rate above 20 mL/min
- Severe liver disease
- Patients with renal failure accompanied by hepatic coma and precoma
- Renal failure due to poisoning with nephrotoxic or hepatotoxic substances
- Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension
- Nursing women
Pregnancy
Treatment with any diuretic, which cannot be discontinued with the required washout period before the first drug administration
Existence of any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with absorption, distribution, metabolism or excretion of drugs.
Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
Treatment with the following inhibitors of secretion at the renal level: clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and verapamil, which cannot be discontinued during the course of the study.

Interfering substance:Subjects must abstain from alcohol and beverages containing stimulating xanthine derivates (e.g. coffee and tea) during the entire study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Investigational Site Number 124002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Furosemide PO - IV

Furosemide IV - PO

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Absolute bioavailability (F) of a single 500-mg oral tablet

Secondary Outcome Measures

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)

To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine

Full Information

NCT ID

NCT01724788

First Posted

October 30, 2012

Last Updated

February 11, 2013

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01724788

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Furosemide PO - IV

Arm Type

Experimental

Arm Description

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)

Arm Title

Furosemide IV - PO

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

FUROSEMIDE

Other Intervention Name(s)

Furosemide Special Injection

Intervention Description

Pharmaceutical form: Solution Route of administration: Intravenous

Intervention Type

Drug

Intervention Name(s)

FUROSEMIDE (HOE058)

Other Intervention Name(s)

Lasix® Special

Intervention Description

Pharmaceutical form: Tablet Route of administration: Oral

Primary Outcome Measure Information:

Title

Absolute bioavailability (F) of a single 500-mg oral tablet

Time Frame

Day 1, 4, 8, 11

Secondary Outcome Measure Information:

Title

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration

Time Frame

Day 1, 4, 8, 11

Title

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration

Time Frame

Day 1, 4, 8, 11

Title

To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)

Time Frame

Day 1, 4, 8, 11

Title

To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine

Time Frame

0, 6, 12, 24 h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Male or female, 18 years old or older, with chronic renal failure undergoing peritoneal dialysis for at least 3 months. Women of childbearing age should have a negative pregnancy test before administration of the study drug Exclusion criteria: Contra-indications to furosemide, including: Hypersensitivity to furosemide or to sulphonamide-derived drugs or to any ingredient in the formulation or component of the container. Glomerular filtration rate below 5 mL/min Glomerular filtration rate above 20 mL/min Severe liver disease Patients with renal failure accompanied by hepatic coma and precoma Renal failure due to poisoning with nephrotoxic or hepatotoxic substances Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension Nursing women Pregnancy Treatment with any diuretic, which cannot be discontinued with the required washout period before the first drug administration Existence of any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with absorption, distribution, metabolism or excretion of drugs. Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance. Treatment with the following inhibitors of secretion at the renal level: clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and verapamil, which cannot be discontinued during the course of the study. Interfering substance:Subjects must abstain from alcohol and beverages containing stimulating xanthine derivates (e.g. coffee and tea) during the entire study period. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 124002

City

Montreal

ZIP/Postal Code

H1T 2M4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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