NCT01986283

Abuse Potential Study of PF-00345439

A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Administered Orally Whole And/or Chewed To Non-dependent, Recreational Opioid Users Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.

Conditions

• Opioid Users

Interventions

Type	Name	Description
DRUG	Capsule	Taken once
DRUG	PF-00345439	40 mg capsule swallowed whole, taken once
DRUG	PF-00345439	40 mg capsule chewed, taken once
DRUG	oxycodone	40 mg solution, taken once

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-18
• Last updated: 2016-04-04

Locations

1 site across 1 country: United States