Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | August 2014 |
An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers
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.
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.
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
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