NCT01530542

A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Analgesia
• Acute Pain
• Chronic Pain
• Narcotic Abuse
• Opioid-related Disorders

Interventions

Type	Name	Description
DRUG	oxycodone hydrochloride	oxycodone hydrochloride 5 mg tablet under fasted conditions
DRUG	oxycodone hydrochloride	2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
DRUG	oxycodone hydrochloride	2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
DRUG	oxycodone hydrochloride	2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
DRUG	marketed oxycodone hydrochloride	1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2012-02-10
• Last updated: 2012-02-24

Locations

1 site across 1 country: United States