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

NCT01530542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-02-24

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530542 on ClinicalTrials.gov