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A Study To Characterize The Pharmacokinetics 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: Management of Moderate to Severe Pain

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

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Clinical Details

Official title: Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions 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-inf)]

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E

Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E

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

Plasma Concentration 24 Hours Post-Dose (C24)

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.

- History of obstructive sleep apnea.

- Positive urine drug test.

Locations and Contacts

Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information

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

Starting date: March 2012
Last updated: October 8, 2012

Page last updated: August 23, 2015

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