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

NCT ID: NCT01724788

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-01-31

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Furosemide PO - IV

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)

Group Type: EXPERIMENTAL

FUROSEMIDE

Intervention Type: DRUG

Pharmaceutical form: Solution Route of administration: Intravenous

FUROSEMIDE (HOE058)

Intervention Type: DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Furosemide IV - PO

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)

Group Type: EXPERIMENTAL

FUROSEMIDE

Intervention Type: DRUG

Pharmaceutical form: Solution Route of administration: Intravenous

FUROSEMIDE (HOE058)

Intervention Type: DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Interventions

FUROSEMIDE

Pharmaceutical form: Solution Route of administration: Intravenous

Intervention Type: DRUG

FUROSEMIDE (HOE058)

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type: DRUG

Other Intervention Names

Furosemide Special Injection; Lasix® Special

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 124002

Montreal, , Canada

Countries

Canada

Other Identifiers

U1111-1127-0839

Identifier Type: OTHER

Identifier Source: secondary_id

FUROSL06121

Identifier Type: -

Identifier Source: org_study_id