Coffee Interaction With the Antihypertensive Drug Felodipine

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine

Conditions
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Food-Drug Interactions

Intervention / Treatment
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* Other: Black Coffee
* Other: Grapefruit Juice
* Other: Water
* Drug: Felodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy (normal physical exam, blood clinical chemistry) willingly signs ethics approved informed consent form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water plus Felodipine<br>Felodipine extended-release tablet ,10 mg, single dose, 8 hours | Other: Water<br> <br> Drug: Felodipine<br> <br> * Other names: Renadil;|
| Active Comparator: Black Coffee<br>Black Coffee, 300 ml, 0 and 1 hour | Other: Black Coffee<br> <br> |
| Experimental: Black Coffee plus Felodipine<br>Black Coffee, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours | Other: Black Coffee<br> <br> Drug: Felodipine<br> <br> * Other names: Renadil;|
| Active Comparator: Grapefruit Juice plus Felodipine<br>Grapefruit Juice, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours | Other: Grapefruit Juice<br> <br> Drug: Felodipine<br> <br> * Other names: Renadil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . | 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). | Change from Baseline to 8 hours Post Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of coffee on the oral pharmacokinetics of felodipine. | Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose | Change from Baseline to 8 hours Post Dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coffee, Grapefruit Juice, Felodipine, Calcium Channel Blocker, Hemodynamics, CYP3A4