A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
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|ClinicalTrials.gov Identifier: NCT01099709|
Recruitment Status : Completed
First Posted : April 7, 2010
Results First Posted : May 6, 2010
Last Update Posted : May 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Reformulated OXY (oxycodone HCl) Drug: Original OxyContin® (OXY) (oxycodone HCl)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||August 2007|
Experimental: Reformulated OXY 10 mg
Reformulated OXY 10 mg x 1 dose
Drug: Reformulated OXY (oxycodone HCl)
Reformulated OXY 10-mg tablet x 1 dose taken with food.
Active Comparator: Original OxyContin® (OXY) 10 mg
Original OxyContin® (OXY) 10 mg x 1 dose
Drug: Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.
- Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ]Bioeqivalence based on Cmax.
- AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over a 72-hour time period ]Bioequivalence based on AUC0-inf
- AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ]Bioequivalence based on AUC0-t
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099709
|United States, Hawaii|
|Covance Clinical Research Unit|
|Honolulu, Hawaii, United States, 96813|