A Randomized, Balanced, Single Dose, Two-treatment (Fed vs. Fasting), Two-period, Two-sequence, Crossover Study to Evaluate the Effects of Food on the Bioavailability of 60 mg ER Torsemide Tablet in Healthy Human Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Total torsemide plasma concentration
研究概览
简要总结
This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers. The study will be conducted as a two-sequence to period crossover study to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER torsemide is a new strength and dosage form.
详细描述
Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure unless dietary salt intake is severely restricted. Extended Release (ER) torsemide is being developed to address this drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet. Since 60mg ER torsemide is a new strength and dosage form, this study will test 60mg ER torsemide for a food effect in healthy volunteers who are either fasting or consuming a high-fat meal (fed). The primary endpoint of the study is full pharmacokinetics measurements after a single dose of 60mg ER torsemide. The secondary endpoints are 24h sodium excretion and total urinary excretion.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male or female
- •non-smoker
- •weight ≥ 50 kg for male and ≥ 45 for female
- •clinically acceptable laboratory profiles with ECG and chest x-ray performed within 6 months
排除标准
- •participation in bioavailability/bioequivalence studies in past six months
- •history of drug abuse or alcohol dependence
- •history of allergies, known hypersensitivity to Torsemide and related drugs
- •presence of clinically significant disorder
- •suffer from high/low blood pressure (<90 and >140 mm Hg)
- •positive urine drug screening, and
- •history of incontinence
研究组 & 干预措施
Fed- 60mg ER Torsemide
Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing
干预措施: Fed- 60mg ER Torsemide (Drug)
Fasting- 60mg ER Torsemide
Adult healthy subjects will fast overnight (at least 10h) prior to dosing
干预措施: Fasting- 60mg ER Torsemide (Drug)
结局指标
主要结局
Total torsemide plasma concentration
时间窗: 36 hours
Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions
Peak torsemide plasma concentration
时间窗: 36 hours
Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions
次要结局
- Urinary torsemide excretion(36 hours)
- Urinary sodium excretion(36 hours)