NCT01924676

Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Detailed description

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers. Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-08-16
• Last updated: 2015-08-31

Locations

1 site across 1 country: United States