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Pharmacokinetics 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); 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 pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Clinical Details

Official title: Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted 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 (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit

Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.

Plasma Decay Half-Life of oxycodone, as data permit.

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

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, New Haven, Connecticut 06511, United States
Additional Information

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

Starting date: November 2012
Last updated: April 15, 2013

Page last updated: August 23, 2015

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