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

NCT01724788 | Completed Phase 1

• 2 other identifiers: FUROSL06121U1111-1127-0839
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

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

  Day 1, 4, 8, 11

Secondary Outcomes (4)

• 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

Study Arms (2)

Furosemide PO - IV

EXPERIMENTAL

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)

Drug: FUROSEMIDE; Drug: FUROSEMIDE (HOE058)

Furosemide IV - PO

EXPERIMENTAL

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)

Drug: FUROSEMIDE; Drug: FUROSEMIDE (HOE058)

Interventions

FUROSEMIDE DRUG

Pharmaceutical form: Solution Route of administration: Intravenous

Also known as: Furosemide Special Injection

Furosemide IV - PO; Furosemide PO - IV

FUROSEMIDE (HOE058) DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Also known as: Lasix® Special

Furosemide IV - PO; Furosemide PO - IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 124002

Montreal, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

CA (1)