A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy Volunteers
Interventions:	Drug: Reformulated OXY (oxycodone HCl) Drug: Original OxyContin® (OXY) (oxycodone HCl)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
02-Jan-2007 to 06-Mar-2007 at 1 site in the US (Madison, WI)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
167 subjects screened; 83 screen failures; 84 randomized; 1 terminated early; 83 completed

Reporting Groups

	Description
Reformulated OXY (Test) First	Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
Original OxyContin® (OXY) (Reference) First	Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.

Participant Flow for 2 periods

Period 1: Period 1

	Reformulated OXY (Test) First	Original OxyContin® (OXY) (Reference) First
STARTED	43	41
COMPLETED	42	41
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Period 2: Period 2

	Reformulated OXY (Test) First	Original OxyContin® (OXY) (Reference) First
STARTED	42	41
COMPLETED	42	41
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Randomized Safety Population	Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.

Baseline Measures

	Randomized Safety Population
Number of Participants [units: participants]	84
Age [units: years] Mean ± Standard Deviation	32 ± 9.3
Gender [units: participants]
Female	27
Male	57

Outcome Measures

Hide All Outcome Measures

1. Primary:

Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ]

Measure Type	Primary
Measure Title	Cmax - Maximum Observed Plasma Concentration
Measure Description	Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Time Frame	Blood samples collected over 72-hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Reporting Groups

	Description
Reformulated OXY (Test)	Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
Original OxyContin® (OXY) (Reference)	Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion

Measured Values

	Reformulated OXY (Test)	Original OxyContin® (OXY) (Reference)
Number of Participants Analyzed [units: participants]	81	81
Cmax - Maximum Observed Plasma Concentration [units: ng/mL] Mean ± Standard Deviation	9.60 ± 2.49	9.38 ± 1.92

Statistical Analysis 1 for Cmax - Maximum Observed Plasma Concentration

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Geometric Test/Ref Ratio x 100 ^[3]	102
90% Confidence Interval	( 99.35 to 105.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

2. Primary:

AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72-hour period ]

Measure Type	Primary
Measure Title	AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Measure Description	AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.
Time Frame	Blood samples collected over 72-hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Reporting Groups

	Description
Reformulated OXY (Test)	Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
Original OxyContin® (OXY) (Reference)	Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion

Measured Values

	Reformulated OXY (Test)	Original OxyContin® (OXY) (Reference)
Number of Participants Analyzed [units: participants]	81	81
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [units: ng*h/mL] Mean ± Standard Deviation	110 ± 25.0	114 ± 28.6

Statistical Analysis 1 for AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Geometric Test/Ref Ratio x 100 ^[3]	98.0
90% Confidence Interval	( 94.94 to 101.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

3. Primary:

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 ]

Measure Type	Primary
Measure Title	AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
Measure Description	AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.
Time Frame	Blood samples collected over 72-hour period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Reporting Groups

	Description
Reformulated OXY (Test)	Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
Original OxyContin® (OXY) (Reference)	Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion

Measured Values

	Reformulated OXY (Test)	Original OxyContin® (OXY) (Reference)
Number of Participants Analyzed [units: participants]	81	81
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration [units: ng*h/mL] Mean ± Standard Deviation	110 ± 25.0	113 ± 28.3

Statistical Analysis 1 for AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Geometric Test/Ref Ratio x 100 ^[3]	98.3
90% Confidence Interval	( 95.20 to 101.48 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

Statistical Analysis 2 for AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Geometric Test/Ref Ratio x 100 ^[3]	98.3
90% Confidence Interval	( 95.20 to 101.48 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).
[3]	Other relevant estimation information:
	Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Stephen Harris, M.D.
Organization: Purdue Pharma L.P.
phone: 203-588-7592
e-mail: Stephen.Harris@Pharma.com

No publications provided

Responsible Party:	Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier:	NCT01100086 History of Changes
Other Study ID Numbers:	OTR1003
Study First Received:	April 6, 2010
Results First Received:	April 13, 2010
Last Updated:	May 17, 2010
Health Authority:	United States: Food and Drug Administration