Pharmacokinetics 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: | November 2012 |
| End Date: | January 2013 |
Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers
To estimate the pharmacokinetics and relative bioavailability of oxycodone after
administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions
and after chewing under fasted conditions in healthy volunteers
administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions
and after chewing under fasted conditions in healthy volunteers
This study will estimate the pharmacokinetics and relative bioavailability of oxycodone
following oral administration of single 40 mg doses of PF-00345439 Formulations J and K
compared with the reference PF-00345439 Formulation A, all taken whole and under fed
conditions in healthy volunteers.
In addition, the study will estimate the pharmacokinetics and relative bioavailability of
oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or
K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to
that taken whole in the fed state in healthy volunteers, and assess the single-dose safety
and tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when
administered under a naltrexone block.
following oral administration of single 40 mg doses of PF-00345439 Formulations J and K
compared with the reference PF-00345439 Formulation A, all taken whole and under fed
conditions in healthy volunteers.
In addition, the study will estimate the pharmacokinetics and relative bioavailability of
oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or
K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to
that taken whole in the fed state in healthy volunteers, and assess the single-dose safety
and tolerability of oxycodone inPF-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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