Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
- Registration Number
- NCT01552850
- Lead Sponsor
- Pain Therapeutics
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
Exclusion Criteria
- Evidence or history of clinically significant diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxycodone Formulation A Capsule Oxycodone single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block Oxycodone Formulation B Capsule Oxycodone single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block Oxycodone Formulation C Capsule Oxycodone single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block Oxycodone Formulation D Capsule Oxycodone single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block Oxycodone Oral Solution Oxycodone 40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose Maximum Observed Plasma Concentration (Cmax) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
- Secondary Outcome Measures
Name Time Method Adverse events, vital signs and laboratory parameters. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose Plasma Decay Half-Life of oxycodone, as data permit. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose Concentration at time 24 hours (C24) of oxycodone, as data permit. 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore