Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Ramipril, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration at steady state
研究概览
简要总结
Study to determine the potential pharmacokinetic interaction of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. This study aims to determine if the steady state study pharmacokinetic parameters of any of the given drugs and the tolerability is altered when administered concomitantly.
详细描述
This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial to compare the pharmacokinetic of ramipril, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the absence and presence of each other.
Bioanalysis of ramipril, ramiprilat, atorvastatin and amlodipine is performed by LC/MS/MS method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Caucasian, aged 18 to 50 years, inclusive.
- •Body Mass Index (BMI) range within 18.5 - 30.0 Kg/m
- •Physically and mentally healthy as judged by means of medical and standard laboratory examinations. Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
- •Standard ECG assessment is normal
- •Informed consent given in written form according to chapter 5.3 of the study protocol.
排除标准
- •Known allergy to the drugs under investigation or any ingredients or any other related drugs.
- •Participation in a relative bioavailability study or in a clinical study within the last 80 days before first study drug administration or blood donation
- •Presence of any clinically significant results from laboratory tests, vital sign assessment and electrocardiogram as judged by the investigator. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- •Results of CPK or liver or kidney function tests which are outside the reference range.
- •Hb test lower than 13.3 g/dl.
- •Positive serologic findings
- •History of drug or alcohol abuse.
- •Subject is a heavy smoker.
- •Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
- •Subject having at screening examination a sitting blood pressure of less than 110/70 mm Hg or more than or equal to 140/90 mm Hg.
- •Subjects who are known or suspected: not to comply with the study directives, not to be reliable or trustworthy, not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed, to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
研究组 & 干预措施
Treatment A-B-C-ABC
The demographic characteristics of the 18 male subjects were as follows:
- Age: 18-49 years
- Weight: 55-105 kg
- Height: 163-188 cm
- BMI 18.5-29.9 kg/m²
干预措施: Ramipril, Amlodipine and Atorvastatin (Drug)
结局指标
主要结局
Maximum Plasma Concentration at steady state
时间窗: up to 24 hours post-administration at steady state
Maximum plasma concentration, it is read directly from the raw data
Area under the Plasma concentration curve (AUC0-t)
时间窗: up to 24 hours post-administration at steady state
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
次要结局
- Safety measurement (Adverse Events)(complete study, Day 1 until Day 31 (Follow-up))
- Time until Cmaxss is reached (tmaxss)(up to 24 hours post-administration at steady state)