Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, Minnesota
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Pain Therapeutics
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Layout table for additonal information
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:
Layout table for MeSH terms
Disease
Pathologic Processes
Oxycodone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents