Coffee Interaction With the Antihypertensive Drug Felodipine

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02232269

Collaborator

(none)

Enrollment

Location

Arms

14.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Food-Drug Interactions	Other: Black Coffee Other: Grapefruit Juice Other: Water Drug: Felodipine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Water plus Felodipine Felodipine extended-release tablet ,10 mg, single dose, 8 hours	Other: Water Drug: Felodipine Other Names: Plendil Renadil
Active Comparator: Black Coffee Black Coffee, 300 ml, 0 and 1 hour	Other: Black Coffee
Experimental: Black Coffee plus Felodipine Black Coffee, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours	Other: Black Coffee Drug: Felodipine Other Names: Plendil Renadil
Active Comparator: Grapefruit Juice plus Felodipine Grapefruit Juice, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours	Other: Grapefruit Juice Drug: Felodipine Other Names: Plendil Renadil

Outcome Measures

Primary Outcome Measures

The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . [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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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