Trial Outcomes & Findings for To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01101178)
NCT ID: NCT01101178
Last Updated: 2011-10-10
Results Overview
Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2011-10-10
Participant Flow
23-Aug-2007 to 26-Nov-2007 at 1 site in the US (Madison, WI).
169 screened; 86 screen failures; 2 discontinued prior to randomization; 81 randomized; 79 randomized and received study drug; 11 terminated early (2 discontinued prior to receiving study drug); 70 completed.
Participant milestones
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 80-mg tablet (test) fed, dose 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) 80-mg tablet (reference) fed, dose 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.
|
|---|---|---|
|
Period 1
STARTED
|
40
|
39
|
|
Period 1
COMPLETED
|
36
|
35
|
|
Period 1
NOT COMPLETED
|
4
|
4
|
|
Period 2
STARTED
|
36
|
35
|
|
Period 2
COMPLETED
|
36
|
34
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 80-mg tablet (test) fed, dose 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) 80-mg tablet (reference) fed, dose 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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
2
|
|
Period 1
Positive drug screen
|
1
|
1
|
|
Period 1
Adverse Event
|
2
|
1
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=79 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
|
29 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: Full Analysis Population for Pharmacokinetic (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 experiencing emesis within 12 hours after dosing were excluded from PK analysis.
Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.
Outcome measures
| Measure |
Reformulated Oxycodone (OXY) (Test)
n=74 Participants
Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=70 Participants
Original OxyContin® (oxycodone \[OXY\]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
109 ng/mL
Standard Deviation 27.9
|
97.6 ng/mL
Standard Deviation 19.9
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: Full Analysis Population for pharmacokinetic (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 experiencing emesis within 12 hours after dosing were excluded from PK analysis.
AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.
Outcome measures
| Measure |
Reformulated Oxycodone (OXY) (Test)
n=74 Participants
Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=70 Participants
Original OxyContin® (oxycodone \[OXY\]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
|
|---|---|---|
|
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
1033 ng*h/mL
Standard Deviation 269
|
1070 ng*h/mL
Standard Deviation 275
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: Full Analysis Population for Pharmacokinetic (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 experiencing emesis within 12 hours after dosing were excluded from PK analysis.
AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t
Outcome measures
| Measure |
Reformulated Oxycodone (OXY) (Test)
n=74 Participants
Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=70 Participants
Original OxyContin® (oxycodone \[OXY\]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
|
|---|---|---|
|
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
|
1030 ng*h/mL
Standard Deviation 267
|
1064 ng*h/mL
Standard Deviation 274
|
Adverse Events
Reformulated OXY (Test)
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Original OxyContin® (OXY) (Reference)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Screening
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reformulated OXY (Test)
n=75 participants at risk
Reformulated OXY 80-mg tablet (test) fed, dose 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.
|
Original OxyContin® (OXY) (Reference)
n=75 participants at risk
Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose 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.
|
Screening
n=169 participants at risk
|
|---|---|---|---|
|
Social circumstances
Positive drug screen (Cannabinoids)
|
0.00%
0/75 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
1.3%
1/75 • Number of events 1 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
1.2%
2/169 • Number of events 2 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Social circumstances
Positive drug screen (Cocaine)
|
1.3%
1/75 • Number of events 1 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/75 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
Other adverse events
| Measure |
Reformulated OXY (Test)
n=75 participants at risk
Reformulated OXY 80-mg tablet (test) fed, dose 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.
|
Original OxyContin® (OXY) (Reference)
n=75 participants at risk
Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose 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.
|
Screening
n=169 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.3%
13/75 • Number of events 21 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
10.7%
8/75 • Number of events 12 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • Number of events 3 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
6.7%
5/75 • Number of events 9 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
General disorders
Fatigue
|
5.3%
4/75 • Number of events 4 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
4.0%
3/75 • Number of events 3 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Dizziness
|
12.0%
9/75 • Number of events 13 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
6.7%
5/75 • Number of events 5 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Headache
|
21.3%
16/75 • Number of events 21 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
18.7%
14/75 • Number of events 15 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Somnolence
|
10.7%
8/75 • Number of events 9 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
10.7%
8/75 • Number of events 9 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/169 • Ongoing adverse events (AEs) followed until resolution/30 days after last dose; AEs reported during 7 days following last dose recorded/followed until resolution/30 days after last dose. SAEs followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
Additional Information
Clinical Leader
Purdue Pharma L.P.
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60