NCT02117583

Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-21
• Last updated: 2016-04-04

Locations

2 sites across 1 country: United States