Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

NCT01552850 — Phase 1, Completed, 18 participants, Pain Therapeutics

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An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers

Registry	NCT01552850
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	18 (Actual)
Sponsor	Pain Therapeutics (Industry)
Conditions	Pain
Interventions	Oxycodone (Drug)
Dates	start 2012-04-01, primary completion 2012-06-01, completion 2012-06-01, first posted 2012-03-13, last updated 2015-08-31
Locations	1 site in Singapore

-Summary

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution

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+Detailed description

This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.

+Arms and interventions

Arm	Type	Interventions	Description
Oxycodone Formulation A Capsule	Experimental	Drug: Oxycodone	single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Oxycodone Formulation B Capsule	Experimental	Drug: Oxycodone	single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Oxycodone Formulation C Capsule	Experimental	Drug: Oxycodone	single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Oxycodone Formulation D Capsule	Experimental	Drug: Oxycodone	single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block
Oxycodone Oral Solution	Experimental	Drug: Oxycodone	40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block

Oxycodone (Drug): 1X40 mg PF-00345439 formulation A capsule with water and under fed condition
Oxycodone (Drug): 1X40 mg PF-00345439 formulation B capsule with water and under fed condition
Oxycodone (Drug): 1X40 mg PF-00345439 formulation C capsule with water and under fed condition
Oxycodone (Drug): 1X40 mg PF-00345439 formulation D capsule with water and under fed condition
Oxycodone (Drug): 40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

+Outcome measures

Primary outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]
Maximum Observed Plasma Concentration (Cmax) [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]

Secondary outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]
Plasma Decay Half-Life of oxycodone, as data permit. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]
Concentration at time 24 hours (C24) of oxycodone, as data permit. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]
Adverse events, vital signs and laboratory parameters. [0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose]

+Eligibility

Sex: All, ages: 21 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant diseases

+Locations (1)

Facility	City	Country	Status
Pfizer Investigational Site	Singapore, Singapore	Singapore

+Investigators

Pfizer CT.gov Call Center, Study director, Pfizer