NCT02059915

Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions

An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Pain Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-02-11
• Last updated: 2016-04-04

Locations

1 site across 1 country: United States