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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530542
• Other study ID #: K234-10-1001
• Secondary ID: B4501006
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: February 22, 2012
• Start date: July 2010
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Adminstration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Chronic Pain
• Narcotic Abuse
• Opioid-related Disorders

Intervention

Drug:
• oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
• oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
• oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
• oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
• marketed oxycodone hydrochloride
1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		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.	No
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Screening up to approximately 3 months	Yes
Secondary	Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)		Screening up to approximately 3 months	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	Change from Baseline to each Post-Dose Assessment in Heart Rate		0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.	Yes
Secondary	Change from Baseline to each Post-Dose Assessment in Respiratory Rate		0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.	Yes
Secondary	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.	Yes
Secondary	Change from Screening to End-of-Study Assessment in Hematology Parameters		Screening up to approximately 3 months	Yes
Secondary	Change from Screening to End-of-Study Assessment in Chemistry Parameters		Screening up to approximately 3 months	Yes
Secondary	Change from Screening to End-of-Study Assessment in Urinalysis Parameters		Screening up to approximately 3 months	Yes
Secondary	Change from Screening to End-of-Study Assessment in ECG Measurements		Screening up to approximately 3 months	Yes

External Links

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