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Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

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NCT01677039

Last updated on April 9, 2020
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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy volunteers

- history of moderate alcohol consumption

- total body weight exceeding 64 kg

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- history of clinically significant disease

- history of sleep apnea

- any condition affecting drug absorption

- pregnant or nursing female subjects

- history of allergy or hypersensitivity to either oxycodone or naltrexone

NCT01677039
Pfizer
Completed
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

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Descriptive Information
Brief Title  ICMJE Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
Official Title  ICMJE An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers
Brief Summary The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Test formulation administered with water
    single dose of 20 mg of test formulation with 240 mL of water
    Other Name: ALO-02 20 mg
  • Drug: Test formulation administered with 20% ethanol
    single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
    Other Name: ALO-02 20 mg
  • Drug: Test formulation administered with 40% ethanol
    single dose of 20 mg of test formulation with 240 mL of 40% ethanol
    Other Name: ALO-02 20 mg
Study Arms  ICMJE
  • Active Comparator: Treatment A
    Intervention: Drug: Test formulation administered with water
  • Experimental: Treatment B
    Intervention: Drug: Test formulation administered with 20% ethanol
  • Experimental: Treatment C
    Intervention: Drug: Test formulation administered with 40% ethanol
Publications * Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012) 		19
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2012) 		18
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteers
  • history of moderate alcohol consumption
  • total body weight exceeding 64 kg

Exclusion Criteria:

  • history of clinically significant disease
  • history of sleep apnea
  • any condition affecting drug absorption
  • pregnant or nursing female subjects
  • history of allergy or hypersensitivity to either oxycodone or naltrexone
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01677039
Other Study ID Numbers  ICMJE B4531004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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