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

NCT01724788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-02-12

No results posted yet for this study

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

Interventions

DRUG

FUROSEMIDE

Pharmaceutical form: Solution Route of administration: Intravenous

DRUG

FUROSEMIDE (HOE058)

Pharmaceutical form: Tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724788 on ClinicalTrials.gov