Effects of Sodium Intake on Pharmacokinetic/Pharmacodynamic Relationship of a Single Dose of a Renin Angiotensin System-Blocker, or a Beta-Blocker in Normotensive Sodium-Depleted or Replated Volunteers in a Cross-Over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
研究概览
简要总结
The impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.
详细描述
The impact of sodium intake on plasma drug concentrations concentrations obtained after a single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg) or a blocker as control (ATENOLOL 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.
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 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •64 (16 per treatment goup) non-smoking healthy male volunteers
- •Aged between 18 and 35 years after a complete clinical examination
- •Safety laboratory measurements
- •Having given written informed consent.
排除标准
- •hypertension
- •known disease
- •diabetes mellitus
- •known hypersensitivity
- •contraindication to ACE inhibitors
- •history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.
研究组 & 干预措施
1
treatment
干预措施: valsartan 160 mg (Drug)
1
treatment
干预措施: high sodium diet (Drug)
1
treatment
干预措施: low sodium diet (Drug)
1
treatment
干预措施: ramipril 10 mg (Drug)
1
treatment
干预措施: candesartan 8 mg (Drug)
1
treatment
干预措施: atenolol 50 mg (Drug)
结局指标
主要结局
Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
时间窗: 48 hours
次要结局
未报告次要终点