Clinical trial NCT01724788: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Failure
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Absolute bioavailability (F) of a single 500-mg oral tablet
timeFrame: Day 1, 4, 8, 11
Secondary outcomes:
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration
timeFrame: Day 1, 4, 8, 11
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration
timeFrame: Day 1, 4, 8, 11
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)
timeFrame: Day 1, 4, 8, 11
measure: To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine
timeFrame: 0, 6, 12, 24 h
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Investigational Site Number 124002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: