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

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02059915

B4501015

Details and patient eligibility

About

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

Enrollment: 134 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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134 participants in 4 patient groups

Treatment A

Experimental group

Description:

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).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment B

Experimental group

Description:

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).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment C

Experimental group

Description:

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).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment D

Experimental group

Description:

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).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone