Abuse Potential Study of PF-00345439
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | August 2014 |
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
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.
(Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release
(IR) tablets and placebo administered orally to non-dependent, recreational opioid users.
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years who are
recreational opioid users and are NOT dependent on opioids.
Exclusion Criteria:
- Evidence or history of clinically significant medical conditions.
- Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
- Has participated in, is currently participating in, or is seeking treatment for
substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
- Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
- Has a positive alcohol breath test.
- Has any history of a condition in which an opioid is contraindicated.
- History of sleep apnea in the past 5 years that has not been resolved or corrected.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results .
- Positive test for Hepatitis B, Hepatitis C, or HIV.
- Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids,
and/or lactose.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
We found this trial at
1
site
Click here to add this to my saved trials
