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Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

NCT02117583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-04-04

No results posted yet for this study

Summary

To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Conditions

  • Healthy

Interventions

DRUG

Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions

DRUG

Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions

DRUG

Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions

DRUG

Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fed conditions

Sponsors & Collaborators

  • Pain Therapeutics

    lead INDUSTRY

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
2014-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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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 NCT02117583 on ClinicalTrials.gov