A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01530542

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Acute Pain Chronic Pain Narcotic Abuse Opioid-related Disorders	Drug: oxycodone hydrochloride Drug: oxycodone hydrochloride Drug: oxycodone hydrochloride Drug: oxycodone hydrochloride Drug: marketed oxycodone hydrochloride	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A	Drug: oxycodone hydrochloride oxycodone hydrochloride 5 mg tablet under fasted conditions
Experimental: Treatment B	Drug: oxycodone hydrochloride 2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Experimental: Treatment C	Drug: oxycodone hydrochloride 2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Experimental: Treatment D	Drug: oxycodone hydrochloride 2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Experimental: Treatment E	Drug: marketed oxycodone hydrochloride 1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.]
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment [0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.]
Change from Baseline to each Post-Dose Assessment in Heart Rate [0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.]
Change from Baseline to each Post-Dose Assessment in Respiratory Rate [0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.]
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %) [0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.]
Change from Screening to End-of-Study Assessment in Hematology Parameters [Screening up to approximately 3 months]
Change from Screening to End-of-Study Assessment in Chemistry Parameters [Screening up to approximately 3 months]
Change from Screening to End-of-Study Assessment in Urinalysis Parameters [Screening up to approximately 3 months]
Change from Screening to End-of-Study Assessment in ECG Measurements [Screening up to approximately 3 months]