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Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oxycodone (Drug); Oxycodone (Drug); Oxycodone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Clinical Details

Official title: An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Concentration at time 24 hours (C24) of oxycodone, as data permit.

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

- Evidence or history of clinically significant disease

- Positive urine drug test

Locations and Contacts

Pfizer Investigational Site, Baltimore, Maryland 21225, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2013
Last updated: October 25, 2013

Page last updated: August 23, 2015

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