Single-Dose, Crossover Study To Compare Bioavailability O... | NCT02059915

NCT02059915

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	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
Treatment B	Experimental	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
Treatment C	Experimental	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
Treatment D	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	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).	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Maximum Observed Plasma Concentration (Cmax)		0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Concentration at time 24 hours (C24)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Saint Paul	Minnesota	55114	United States

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

Intervention Browse Module