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marketed oxycodone

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

marketed oxycodone · 1 trial · 5 indications

Phase 1 1
NCT01530542A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy VolunteersAnalgesia
COMPLETED35 Analytics
PHASE1COMPLETED
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
Analgesia
NCT0153054235
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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 to 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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Frequently asked questions about marketed oxycodone

What is marketed oxycodone used for?

Marketed oxycodone is used for analgesia, which is the relief of pain. It is being studied for conditions including acute pain, chronic pain, narcotic abuse, and opioid-related disorders. The drug is a small molecule being developed by Pfizer, Inc. for the psychiatry therapeutic area.

Who makes marketed oxycodone?

Pfizer, Inc. (NYSE: PFE) is the developer of marketed oxycodone. The company is conducting clinical research on this small molecule for analgesia and related pain conditions.

What phase is marketed oxycodone in?

Marketed oxycodone is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug is not currently in active trials.

What clinical trials is marketed oxycodone in?

Marketed oxycodone has one completed clinical trial, NCT01530542, titled "A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers." This Phase 1 study enrolled 35 healthy volunteers in the United States and was a randomized, controlled trial.

Is marketed oxycodone the same as oxycodone?

Marketed oxycodone is the drug oxycodone itself, studied in a clinical trial to characterize its pharmacokinetics and the effects of food. The trial included healthy volunteers and assessed the drug's behavior in the body.