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Trial record 79 of 663 for:    OXYCODONE

Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

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ClinicalTrials.gov Identifier: NCT01456507
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Condition or disease Intervention/treatment Phase
Healthy Drug: ALO-02 (Oxycodone Naltrexone) Phase 1

Detailed Description:
Bioavailability

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
Study Start Date : October 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
Drug: ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fasting condition

Experimental: B
1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
Drug: ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fed condition

Experimental: C
1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.
Drug: ALO-02 (Oxycodone Naltrexone)
ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.




Primary Outcome Measures :
  1. Area Under the Curve (AUC) to time infinity (inf) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  2. Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  3. Maximum Plasma Concentration (Cmax) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]

Secondary Outcome Measures :
  1. C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  2. AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit [ Time Frame: predose, 1,2,4,8,12,24,48,120 hours post-dose ]
  3. Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. [ Time Frame: over 120 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456507


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01456507     History of Changes
Other Study ID Numbers: B4531003
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Keywords provided by Pfizer:
Food effect
bioavailability
oxycodone
sequestered Naltrexone
management of moderate to severe pain
Additional relevant MeSH terms:
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Oxycodone
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists