Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
67 participants
INTERVENTIONAL
2013-11-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment A
Placebo solution +placebo capsule + placebo capsule chewed.
Capsule
Taken once
Treatment B
PF-00345439 taken whole + placebo solution + placebo chewed
PF-00345439
40 mg capsule swallowed whole, taken once
Treatment C
PF-00345439 chewed + placebo solution + placebo taken whole
PF-00345439
40 mg capsule chewed, taken once
Treatment D
Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed
oxycodone
40 mg solution, taken once
Interventions
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Capsule
Taken once
PF-00345439
40 mg capsule swallowed whole, taken once
PF-00345439
40 mg capsule chewed, taken once
oxycodone
40 mg solution, taken once
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
55 Years
ALL
Yes
Sponsors
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Pain Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Lifetree Clinical Research
Salt Lake City, Utah, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4501016
Identifier Type: -
Identifier Source: org_study_id
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