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marketed oxycodone

Phase 1

Analgesia | Small molecule | Pain |Pfizer, Inc.|Last Updated: Feb 24, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01530542A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy VolunteersPHASE1 COMPLETED 35 — — Jul 1, 2010Sep 1, 2010Feb 24, 20121 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area under the Concentration-Time Curve (AUC)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Secondary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Screening up to approximately 3 months
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Screening up to approximately 3 months
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CEXPERIMENTAL -
Treatment DEXPERIMENTAL -
Treatment EEXPERIMENTAL -
Interventions
NameTypeDescription
oxycodone hydrochlorideDRUGoxycodone hydrochloride 5 mg tablet under fasted conditions
marketed oxycodone hydrochlorideDRUG1 x oxycodone hydrochloride 15 mg tablet under fed conditions
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male 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.

Countries:United States
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