Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552850

B4501010

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 5 patient groups

Oxycodone Formulation A Capsule

Experimental group

Description:

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Oxycodone Formulation B Capsule

Experimental group

Description:

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Oxycodone Formulation C Capsule

Experimental group

Description:

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Oxycodone Formulation D Capsule

Experimental group

Description:

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Oxycodone Oral Solution

Experimental group

Description:

40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone