Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | October 2013 |
An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers
To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg
doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to
PF-00345439 Formulation X in the fasted state in healthy volunteers
doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to
PF-00345439 Formulation X in the fasted state in healthy volunteers
This study will estimate the effect of food (standard high-fat breakfast) on the
pharmacokineticsand relative bioavailability of oxycodone following oral administration of
single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.
Additionally, the study will estimate the pharmacokinetics and relative bioavailability of
oxycodone following oral administration of single 40 mg doses of the test PF-00345439
Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions
in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in
PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.
pharmacokineticsand relative bioavailability of oxycodone following oral administration of
single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.
Additionally, the study will estimate the pharmacokinetics and relative bioavailability of
oxycodone following oral administration of single 40 mg doses of the test PF-00345439
Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions
in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in
PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.
Inclusion Criteria:
- Healthy male and/or female subjects between 18 and 55 years of age (inclusive).
Exclusion Criteria:
- Evidence or history of clinically significant disease
- Positive urine drug test
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