A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
研究概览
简要总结
The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are currently on treatment with any of the following diuretics
- •Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
- •Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
- •Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
- •Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
- •Subjects who are currently hospitalized or who are able to be hospitalized during the trial
排除标准
- •Subjects with acute heart failure
- •Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
- •Subjects who are unable to sense thirst or who have difficulty with fluid intake
研究组 & 干预措施
OPC-61815 injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
干预措施: OPC-61815 injection 2mg (Drug)
OPC-61815 injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
干预措施: OPC-61815 injection 4mg (Drug)
OPC-61815 injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
干预措施: OPC-61815 injection 8mg (Drug)
OPC-61815 injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
干预措施: OPC-61815 injection 16mg (Drug)
Tolvaptan tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
干预措施: Tolvaptan tablet 15mg (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
时间窗: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1
时间窗: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
次要结局
未报告次要终点