A Pharmacokinetic and Pharmacodynamic Study Comparing Metoprolol IR and Metoprolol CR/XL Subsequent to Initial Treatment With Intravenous and/or Oral Metoprolol in Patients With Suspected Acut Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 主要终点
- Pharmacokinetic profile in terms of Cmax, Cmin, AUC
研究概览
简要总结
The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following:
Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve.
Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.
详细描述
A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients admitted to the CCU with suspected acute myocardial infarction
- •Age 18 years or older
- •Treated with and tolerated the full dose of metoprolol IR 50 mr four times daily or metoprolol CR/XL 200 mg once daily on study day 1
- •Expected to stay in the CCU until the morning of study day 4
- •Sinus rhythm on the day of admission and at randomisation
排除标准
- •Pregnancy or childbearing potential without adequate contraception
- •Participation in a clinical study during the last 30 days or previous randomisation in the present study
研究组 & 干预措施
Metoprolol- Toprol XL
Metoprolol extended release (CR/XL) tablet 200 mg once daily
干预措施: Metoprolol- Toprol XL (Drug)
Metoprolol- Lopressor
Metoprolol immediate release (IR) tablet
干预措施: Metoprolol- Lopressor (Drug)
结局指标
主要结局
Pharmacokinetic profile in terms of Cmax, Cmin, AUC
时间窗: Treatment duration: 4 days
Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)
时间窗: Treatment duration: 4 days
Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses
Safety profile in terms of adverse events
时间窗: Treatment duration: 4 days
次要结局
未报告次要终点