Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
研究概览
简要总结
Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world.
Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago.
We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy (normal physical exam, blood clinical chemistry)
- •willingly signs ethics approved informed consent form
排除标准
- •history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse
- •significant illness within 2 weeks of starting study
- •history of allergy to felodipine , tablet ingredients or dihydropyridines
- •routinely taking prescription or OTC drugs or natural health products
- •received an investigational drug withing the previous 4 weeks
- •females who are pregnant or breast-feeding
研究组 & 干预措施
Water plus Felodipine
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Water (Other)
Water plus Felodipine
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Felodipine (Drug)
Black Coffee
Black Coffee, 300 ml, 0 and 1 hour
干预措施: Black Coffee (Other)
Black Coffee plus Felodipine
Black Coffee, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Black Coffee (Other)
Black Coffee plus Felodipine
Black Coffee, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Felodipine (Drug)
Grapefruit Juice plus Felodipine
Grapefruit Juice, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Grapefruit Juice (Other)
Grapefruit Juice plus Felodipine
Grapefruit Juice, 300 ml, 0 and 1 hour
Felodipine extended-release tablet ,10 mg, single dose, 8 hours
干预措施: Felodipine (Drug)
结局指标
主要结局
The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure .
时间窗: Change from Baseline to 8 hours Post Dose
Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA).
次要结局
- The effect of coffee on the oral pharmacokinetics of felodipine.(Change from Baseline to 8 hours Post Dose)
研究者
David Bailey
Principal Investigator
Lawson Health Research Institute