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FUROSEMIDE

Phase 1

Renal Failure | Small molecule | Nephrology |Sanofi|Last Updated: Feb 12, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

FUROSEMIDE · 1 trial · 1 indication

Phase 1 1
NCT01724788Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal DialysisRenal Failure
COMPLETED12 Analytics
PHASE1COMPLETED
Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
Renal FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute bioavailability (F) of a single 500-mg oral tablet
Day 1, 4, 8, 11

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Furosemide PO - IVEXPERIMENTALOral 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)
Furosemide IV - POEXPERIMENTALIV 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)

Interventions

NameTypeDescription
FUROSEMIDEDRUGPharmaceutical form: Solution Route of administration: Intravenous
FUROSEMIDE (HOE058)DRUGPharmaceutical form: Tablet Route of administration: Oral
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 furo...

Countries:Canada
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