Coffee Interaction With the Antihypertensive Drug Felodipine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans

NCT01523028

Healthy

COMPLETED NA

Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

NCT01526213

Food-drug Interaction

COMPLETED NA

Effect of Oral Caffeine and L-Citrulline Supplementation on Arterial Function in Healthy Males

NCT02214290

Hypertension Healthy

COMPLETED NA

Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults

NCT03409497

Glycemic Response Appetitive Behavior

COMPLETED NA

Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

NCT01312597

Neurodegeneration

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Food-Drug Interactions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Water plus Felodipine

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Felodipine

Intervention Type DRUG

Black Coffee

Black Coffee, 300 ml, 0 and 1 hour

Group Type ACTIVE_COMPARATOR

Black Coffee

Intervention Type OTHER

Black Coffee plus Felodipine

Black Coffee, 300 ml, 0 and 1 hour

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

Group Type EXPERIMENTAL

Black Coffee

Intervention Type OTHER

Felodipine

Intervention Type DRUG

Grapefruit Juice plus Felodipine

Grapefruit Juice, 300 ml, 0 and 1 hour

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

Group Type ACTIVE_COMPARATOR

Grapefruit Juice

Intervention Type OTHER

Felodipine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Black Coffee

Intervention Type OTHER

Grapefruit Juice

Intervention Type OTHER

Water

Intervention Type OTHER

Felodipine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Plendil Renadil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes