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

NCT02059915 | Completed Phase 1

• 1 other identifier: B4501015
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

pharmacokinetics; bioequivalence; bioavailability; oxycodone

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  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).

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

• Maximum Observed Plasma Concentration (Cmax)

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary Outcomes (4)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

• Concentration at time 24 hours (C24)

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

• Plasma Decay Half-Life (t1/2)

  0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Study Arms (4)

Treatment A

EXPERIMENTAL

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

Treatment B

EXPERIMENTAL

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

Treatment C

EXPERIMENTAL

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

Treatment D

EXPERIMENTAL

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

Interventions

Oxycodone DRUG

One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions

Treatment A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects between 18 and 55 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Pain Therapeutics: lead

Study Sites (1)

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 4, 2016

Record last verified: 2014-08

Locations

US (1)