Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Concentration-time profile in plasma
研究概览
简要总结
Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.
Treatment in period A is the "Basel phenotyping cocktail" capsule. Treatment in period B consists of simultaneous intake of isolated formulations. In both study arms peripheral venous and capillary blood (DBS) samples will be drawn
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years old
- •Caucasian male volunteers
- •Body mass index (BMI)18-30kg/m2,weight more than 50kg
- •Full mental and legal capacity
- •Signed informed consent prior to any study related procedure
- •Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol
- •Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm*, after 5min in the supine position at screening Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG)
- •Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening
- •No other conditions or circumstances that might interfere with compliance with study protocol
排除标准
- •Known hypersensitivity to any excipients of the drug formulations.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
- •History or presence of smoking (within the last 3months prior to screening) or alcohol or drug abuse
- •Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary supplements within 2weeks prior to the intended start of study.
- •Excessive caffeine consumption, defined as >800 mg per day at Screening Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450
研究组 & 干预措施
"Basel phenotyping cocktail" capsule
干预措施: "Basel phenotyping cocktail" capsule (Other)
"Basel phenotyping cocktail" individual components
干预措施: "Basel phenotyping cocktail" individual components (Other)
结局指标
主要结局
Concentration-time profile in plasma
时间窗: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
Concentration-time profile in capillary blood
时间窗: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
次要结局
未报告次要终点