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

Study Overview
=================
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.

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

Conditions
-----------------
Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders

Intervention / Treatment
-----------------
* Drug: oxycodone hydrochloride
* Drug: oxycodone hydrochloride
* Drug: oxycodone hydrochloride
* Drug: oxycodone hydrochloride
* Drug: marketed oxycodone hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: oxycodone hydrochloride<br>* oxycodone hydrochloride 5 mg tablet under fasted conditions<br>|
| Experimental: Treatment B<br> | Drug: oxycodone hydrochloride<br>* 2 x oxycodone hydrochloride 5 mg tablets under fasted conditions<br>|
| Experimental: Treatment C<br> | Drug: oxycodone hydrochloride<br>* 2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions<br>|
| Experimental: Treatment D<br> | Drug: oxycodone hydrochloride<br>* 2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions<br>|
| Experimental: Treatment E<br> | Drug: marketed oxycodone hydrochloride<br>* 1 x oxycodone hydrochloride 15 mg tablet under fed conditions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain