NCT01552863

A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation A, single dose
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation E, single dose
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation F, single dose
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation G, single dose
DRUG	Oxycodone	One capsule of 5 mg PF-00345439 Formulation TBD, single dose
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation H, single dose

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-03-13
• Last updated: 2015-08-31

Locations

1 site across 1 country: United States