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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Absolute bioavailability (F) of a single 500-mg oral tablet
研究概览
简要总结
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
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Furosemide PO - IV
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)
干预措施: FUROSEMIDE (Drug)
Furosemide PO - IV
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)
干预措施: FUROSEMIDE (HOE058) (Drug)
Furosemide IV - PO
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)
干预措施: FUROSEMIDE (Drug)
Furosemide IV - PO
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)
干预措施: FUROSEMIDE (HOE058) (Drug)
结局指标
主要结局
Absolute bioavailability (F) of a single 500-mg oral tablet
时间窗: Day 1, 4, 8, 11
次要结局
- 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)