Coffee Interaction With the Antihypertensive Drug Felodipine

NCT02232269 | Completed Phase 1

• 2 other identifiers: R-11-655NA-7122
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Food-Drug Interactions

Keywords

Coffee; Grapefruit Juice; Felodipine; Calcium Channel Blocker; Hemodynamics; CYP3A4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of coffee on the oral pharmacokinetics of felodipine.

  Change from Baseline to 8 hours Post Dose

Study Arms (4)

Water plus Felodipine

PLACEBO COMPARATOR

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

Other: Water; Drug: Felodipine

Black Coffee

ACTIVE COMPARATOR

Black Coffee, 300 ml, 0 and 1 hour

Other: Black Coffee

Black Coffee plus Felodipine

EXPERIMENTAL

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

Other: Black Coffee; Drug: Felodipine

Grapefruit Juice plus Felodipine

ACTIVE COMPARATOR

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

Other: Grapefruit Juice; Drug: Felodipine

Interventions

Black Coffee OTHER

Black Coffee; Black Coffee plus Felodipine

Grapefruit Juice OTHER

Grapefruit Juice plus Felodipine

Water OTHER

Water plus Felodipine

Felodipine DRUG

Also known as: Plendil, Renadil

Black Coffee plus Felodipine; Grapefruit Juice plus Felodipine; Water plus Felodipine

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy (normal physical exam, blood clinical chemistry)
• willingly signs ethics approved informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Clinical Trials Centre

London, Ontario, Canada

Location

Related Publications (2)

• Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081.

  PMID: 27481881 BACKGROUND

• Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346.

  PMID: 28971609 BACKGROUND

MeSH Terms

Interventions

Water; Felodipine

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David G Bailey, BScPhm, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 5, 2014
• Study Start: February 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)