Clinical trial NCT01552863: A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: pharmacokinetics
bioavailability
oxycodone.
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2012-03-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Eligibility 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.

Primary outcomes:
measure: Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
measure: Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
measure: Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
measure: Plasma Concentration 24 Hours Post-Dose (C24)
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: