Once‐Daily Oxycodone Prolonged‐Release Tablets Are Resistant to Alcohol‐Induced Dose Dumping: Results From a Randomized Trial in Healthy Volunteers

Autor: Janice Faulkner, Douglas Fraser, Hélène Rey, Nils Burger, Martina Alice Maritz
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Administration
Oral
Alcohol
law.invention
Food-Drug Interactions
chemistry.chemical_compound
Randomized controlled trial
law
Medicine
General Pharmacology
Toxicology and Pharmaceutics
Cross-Over Studies
General Neuroscience
lcsh:Public aspects of medicine
Fasting
Articles
General Medicine
Middle Aged
Healthy Volunteers
Area Under Curve
Anesthesia
Female
Oxycodone
Half-Life
Tablets
medicine.drug
Adult
Adolescent
Alcohol Drinking
Biological Availability
Drug Administration Schedule
Article
General Biochemistry
Genetics and Molecular Biology
Young Adult
Pharmacokinetics
Dose dumping
Humans
Ethanol
business.industry
Research
lcsh:RM1-950
lcsh:RA1-1270
Crossover study
Bioavailability
lcsh:Therapeutics. Pharmacology
chemistry
Opioid
Gastrointestinal Absorption
Delayed-Action Preparations
business
Zdroj: Clinical and Translational Science, Vol 13, Iss 3, Pp 539-546 (2020)
Clinical and Translational Science
ISSN: 1752-8054
1752-8062
Popis: The objective of this study was to determine the effect of concomitant alcohol intake on the bioavailability of oxycodone from an oxycodone once‐daily (OOD) formulation and an oxycodone twice‐daily (OTD) formulation. A phase I, open‐label, randomized, crossover alcohol interaction study in 20 healthy volunteers under fasting conditions was conducted. Participants received five treatments, OOD with 240 mL of 0%, 20%, or 40% alcohol; and OTD with 240 mL of 0% or 40% alcohol. Pharmacokinetic parameters did not differ between participants taking OOD with water or with 240 mL of 20% alcohol. There was a slight increase in overall oxycodone absorption from OOD with 40% alcohol but no increase in peak absorption. Oxycodone absorption from OTD showed peak and overall increases with 40% alcohol but maintained a prolonged‐release profile. Although it is recommended that alcohol be avoided while taking opioids, there was no evidence of alcohol‐induced dose dumping in these oxycodone formulations.
Databáze: OpenAIRE
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