A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
CompletedPhase 1NCT01530542
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
Study details
- Official title
- Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers
- Conditions
- Analgesia
- Acute Pain
- Chronic Pain
- Narcotic Abuse
- Opioid-related Disorders
- Interventions
- Drug: oxycodone hydrochloride
- Drug: oxycodone hydrochloride
- Drug: oxycodone hydrochloride
- Drug: oxycodone hydrochloride
- Drug: marketed oxycodone hydrochloride
- Sponsor
- Pfizer
- Start date
- 2010-07
- Primary completion
- 2010-09
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Healthy male or female subjects between 18 and 55 years of age (inclusive) Exclusion Criteria: * Evidence or history of clinically significant disease; * History of obstructive sleep apnea; * Positive urine drug test.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01530542