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Healthy | Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

Healthy research study

What is the primary objective of this study?

To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions

Drug:OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions

Drug:OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions

Drug:OxycodoneOne capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fed conditions

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Treatment ASingle 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 BSingle 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 CSingle 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 DSingle 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).

Study Status

Completed

Start Date: April 2014

Completed Date: August 2014

Phase: Phase 1

Type: Interventional

Design:

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

Secondary Outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pain Therapeutics

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02117583

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