Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Naltrexone; Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02165930

B4501037

Details and patient eligibility

About

To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers

Enrollment: 17 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• History of moderate alcohol consumption
• Total body weight exceeding 64 kg

Exclusion criteria

• Evidence or history of clinically significant disease.
• Positive urine drug test
• History of alcoholism or heavy alcohol consumption

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Treatment A

Experimental group

Treatment:

Drug: Oxycodone

Drug: Naltrexone

Drug: Naltrexone

Drug: Oxycodone

Treatment B

Experimental group

Treatment:

Drug: Oxycodone

Drug: Naltrexone

Drug: Naltrexone

Drug: Oxycodone