Coffee Interaction With the Antihypertensive Drug Felodipine

Lawson Health Research Institute

Status and phase: Completed; Phase 1

Conditions: Food-Drug Interactions

Treatments: Other: Water; Other: Grapefruit Juice; Drug: Felodipine; Other: Black Coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT02232269

R-11-655

NA-7122 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups, including a placebo group

Water plus Felodipine

Placebo Comparator group

Description:

Felodipine extended-release tablet ,10 mg, single dose, 8 hours

Treatment:

Drug: Felodipine

Other: Water

Black Coffee

Active Comparator group

Description:

Black Coffee, 300 ml, 0 and 1 hour

Treatment:

Other: Black Coffee

Black Coffee plus Felodipine

Experimental group

Description:

Black Coffee, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours

Treatment:

Other: Black Coffee

Drug: Felodipine

Grapefruit Juice plus Felodipine

Active Comparator group

Description:

Grapefruit Juice, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours

Treatment:

Drug: Felodipine

Other: Grapefruit Juice