NCT02165930

Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
DRUG	Naltrexone	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).
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
DRUG	Naltrexone	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).

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-06-18
• Last updated: 2016-04-04

Locations

2 sites across 1 country: United States