Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 12
- 主要终点
- Overall summary of adverse events as a measure of safety and tolarability
研究概览
简要总结
The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
详细描述
- Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as loose combination (Treatment A)
- Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as loose combination (Treatment B)
- Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as loose combination (Treatment C) Before any study drug administration in each treatment period, subjects were fasted from food for at least 10 hours. Subjects continued fasting until at least 4 hours after study drug administration. The wash-out phase between treatments was 5 days.
The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.
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
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
- •Age 30-55 years
- •BMI 18.0-29.9 kg/m²
- •Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
排除标准
- 未提供
研究组 & 干预措施
Nifedipine + Candesartan cilexetil
Coadministration of single doses of nifedipine and candesartan tablets
干预措施: Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil (Drug)
结局指标
主要结局
Overall summary of adverse events as a measure of safety and tolarability
时间窗: 7 weeks
Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events.
Safety related laboratory findings
时间窗: 7 weeks
Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal.
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D)
时间窗: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D)
时间窗: 48 hours
Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax)
时间窗: 48 hours
Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC)
时间窗: 48 hours
次要结局
- Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm)(48 hours)
- Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm)(48 hours)
- Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn))(48 hours)
- Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax)(48 hours)
- Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2)(48 hours)
- Pharmacokinetic parameters: Mean residence time (MRT)(48 hours)
- Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f)(48 hours)