A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Chronic Pain; Narcotic Abuse; Analgesia; Opioid-related Disorders; Acute Pain

Treatments: Drug: marketed oxycodone hydrochloride; Drug: oxycodone hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01530542

K234-10-1001

B4501006

Details and patient eligibility

About

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects between 18 and 55 years of age (inclusive)

Exclusion criteria

• Evidence or history of clinically significant disease;
• History of obstructive sleep apnea;
• Positive urine drug test.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 5 patient groups

Treatment A

Experimental group

Treatment:

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Treatment B

Experimental group

Treatment:

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Treatment C

Experimental group

Treatment:

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Treatment D

Experimental group

Treatment:

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Drug: oxycodone hydrochloride

Treatment E

Experimental group

Treatment:

Drug: marketed oxycodone hydrochloride