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Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions

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ClinicalTrials.gov Identifier: NCT02059915
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

Brief Summary:
To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxycodone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
Experimental: Treatment A
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions

Experimental: Treatment B
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions

Experimental: Treatment C
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions

Experimental: Treatment D
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Concentration at time 24 hours (C24) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]


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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 18 and 55 years of age

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Positive urine drug test

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): NCT02059915


Locations
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United States, Minnesota
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pain Therapeutics
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT02059915     History of Changes
Other Study ID Numbers: B4501015
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: August 2014
Keywords provided by PainT ( Pain Therapeutics ):
pharmacokinetics
bioequivalence
bioavailability
oxycodone
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents