NCT01552850

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution

Detailed description

This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone	1X40 mg PF-00345439 formulation A capsule with water and under fed condition
DRUG	Oxycodone	1X40 mg PF-00345439 formulation B capsule with water and under fed condition
DRUG	Oxycodone	1X40 mg PF-00345439 formulation C capsule with water and under fed condition
DRUG	Oxycodone	1X40 mg PF-00345439 formulation D capsule with water and under fed condition
DRUG	Oxycodone	40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-03-13
• Last updated: 2015-08-31

Locations

1 site across 1 country: Singapore