Food-Drug Interactions Clinical Trial
Official title:
Phase 1 Study of the Hemodynamic and Pharmacokinetic Interactions Between Coffee and Felodipine
| Verified date | August 2018 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | May 2013 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Victoria Clinical Trials Centre | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Canada,
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. — View Citation
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). doi: 10.1002/prp2.346. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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