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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Failure

Intervention: FUROSEMIDE (Drug); FUROSEMIDE (HOE058) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Investigational Site Number 124002, Montreal H1T 2M4, Canada
Additional Information

Starting date: November 2012
Last updated: February 11, 2013

Page last updated: August 23, 2015

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