Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers: An Open-Label, Randomized, Crossover Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
The purpose of the study was to investigate the potential interaction between ivabradine and bisoprolol in healthy subjects.
详细描述
The aim of this study is to undergo a pharmacokinetic study to investigate the incidence of potential pharmacokinetic interaction between Ivabradine and Bisoprolol through the Assessment of the drug-drug interactions of Ivabradine and Bisoprolol by determination of pharmacokinetic parameters of both drugs administered alone and in combination. The pharmacokinetic parameters will include; The maximum plasma concentration (Cmax),the time to reach the peak concentration (tmax), area under the concentration-time curve (AUC0-t) and (AUC0-∞) during the treatment periods, the absorption and elimination rate constants (ka and kel), the half-life and mean residence time (MRT).
Study design A comparative randomized open-label three-period crossover study of ivabradine/ bisoprolol in male healthy human volunteers
Methodology
Eighteen healthy volunteer will be recruited in the study and will be divided into three groups each consisting of six volunteers as follows:
Period I:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- •Subjects should be healthy adult volunteers with age between (18-45 years) with normal body weight. Subjects should understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures. The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests [hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).
排除标准
- •Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- •Subjects who have taken any medication less than two weeks of the trials starting date.
- •Susceptibility to allergic reactions to study drugs.
- •Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- •Gastrointestinal diseases.
- •Renal diseases.
- •Cardiovascular diseases.
- •Pancreatic disease including diabetes.
- •Hepatic diseases.
- •Hematological disease or pulmonary disease
- •Abnormal laboratory values.
- •Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.
研究组 & 干预措施
Group Ivabradine
six healthy volunteers will administer Ivabradin tablet only once single 10 mg oral dose
干预措施: Ivabradine (Drug)
Group Bisoprolol
six healthy volunteers will administer bisoprolol tablet only once single oral dose of 5mg
干预措施: Bisoprolol (Drug)
Group combination
six healthy volunteers will administer only once a combination of a single dose of ivabradine 10 mg and bisoprolol 5 mg
干预措施: combination of Ivabradine and bisoprolol (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: 48 hours
AUC0→t
Bioavailability parameters
时间窗: 48 hours
t max
次要结局
未报告次要终点
研究者
Sara Mahmoud Shaheen
Associate Professor, Faculty of pharmacy, Ain Shams University
Ain Shams University