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
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Pharmaceutical form: Solution Route of administration: Intravenous
Pharmaceutical form: Tablet Route of administration: Oral
Investigational Site Number 124002
Montreal, Canada
Absolute bioavailability (F) of a single 500-mg oral tablet
Time frame: Day 1, 4, 8, 11
To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 0, 6, 12, 24 h
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