Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions
|
| Experimental: Treatment B Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions
|
| Experimental: Treatment C Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions
|
| Experimental: Treatment D Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). |
Drug: Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fed conditions
|
Outcome Measures
Primary Outcome Measures
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
- Maximum Observed Plasma Concentration (Cmax) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
Secondary Outcome Measures
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Concentration at time 24 hours (C24) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
- Plasma Decay Half-Life (t1/2) [0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects between 18 and 55 years of age
Exclusion Criteria:
-
Evidence or history of clinically significant disease.
-
Positive urine drug test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Overland Park | Kansas | United States | 66211 |
| 2 | Pfizer Investigational Site | Overland Park | Kansas | United States | 66212 |
Sponsors and Collaborators
- Pain Therapeutics
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B4501039