NCT01717027

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Detailed description

This study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulations J and K compared with the reference PF-00345439 Formulation A, all taken whole and under fed conditions in healthy volunteers. In addition, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that taken whole in the fed state in healthy volunteers, and assess the single-dose safety and tolerability of oxycodone inPF-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 A, single dose, taken whole and under fed conditions
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions
DRUG	Oxycodone	One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-10-30
• Last updated: 2015-08-31

Locations

1 site across 1 country: United States