A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
Phase 1
Completed
- Conditions
- AnalgesiaAcute PainChronic PainNarcotic AbuseOpioid-related Disorders
- Interventions
- Registration Number
- NCT01530542
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment E marketed oxycodone hydrochloride - Treatment A oxycodone hydrochloride - Treatment C oxycodone hydrochloride - Treatment B oxycodone hydrochloride - Treatment D oxycodone hydrochloride -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸San Antonio, Texas, United States