A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | September 2012 |
Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will
be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics
of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and
eliminated by the body). This study will consist of three parts that will take place over
approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have
one dosing period each.
be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics
of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and
eliminated by the body). This study will consist of three parts that will take place over
approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have
one dosing period each.
This study will estimate the PK and relative BA of oxycodone following single oral 40-mg
doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference
PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in
selection of a final formulation.
doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference
PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in
selection of a final formulation.
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.
- History of obstructive sleep apnea.
- Positive urine drug test.
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