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marketed oxycodone

Phase 1

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

marketed oxycodone target and mechanism

ModalitySmall molecule

Also known as marketed oxycodone hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

marketed oxycodone clinical trials

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?

Marketed oxycodone is a small molecule analgesic developed by Pfizer, Inc. (ticker: PFE) for analgesia. It is also known as marketed oxycodone hydrochloride. It is used in pain-related settings, and the clinical program has included conditions such as acute pain, chronic pain, and opioid-related disorders.

What is marketed oxycodone used for?

Marketed oxycodone is used for analgesia. Trial documentation also lists acute pain, chronic pain, narcotic abuse, and opioid-related disorders among the conditions studied. It is a small molecule developed by Pfizer, Inc. (PFE) and is referenced under the alternative name marketed oxycodone hydrochloride.

Who makes marketed oxycodone?

Marketed oxycodone is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company named in connection with the clinical development program for this small molecule analgesic. The program includes one completed Phase 1 trial conducted in the United States.

What phase is marketed oxycodone in?

Marketed oxycodone has been studied in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was randomized, controlled, and enrolled 35 participants. It is an investigational asset in the clinical development stage rather than a newly approved product.

What clinical trials is marketed oxycodone in?

Marketed oxycodone has been evaluated in one completed Phase 1 trial, NCT01530542, titled A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers. The trial enrolled 35 healthy volunteers aged 18 years and older, included both sexes, was randomized and controlled, and was conducted in the United States.

Is marketed oxycodone the same as marketed oxycodone hydrochloride?

Yes. Marketed oxycodone hydrochloride is an alternative name for marketed oxycodone, so searches using either name refer to the same asset. It is a small molecule analgesic developed by Pfizer, Inc. (PFE) and studied in a completed Phase 1 pharmacokinetic and food-effect trial, NCT01530542.

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