Trial Outcomes & Findings for To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01101165)
NCT ID: NCT01101165
Last Updated: 2010-05-11
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
92 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2010-05-11
Participant Flow
05-Feb-2007 (first Informed Consent Form signed) to 06-Apr-2007 (last subject follow-up) at 1 site in the US (Evansville, IN).
225 subjects screened; 119 screen failures; 92 randomized and dosed; 12 discontinued and received study drug; 13 discontinued but did not receive study drug; 80 completed.
Participant milestones
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 40-mg tablet (test) fasted, 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) 40-mg tablet (reference) fasted, 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
|
47
|
45
|
|
Period 1
COMPLETED
|
45
|
40
|
|
Period 1
NOT COMPLETED
|
2
|
5
|
|
Period 2
STARTED
|
45
|
40
|
|
Period 2
COMPLETED
|
41
|
39
|
|
Period 2
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 40-mg tablet (test) fasted, 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) 40-mg tablet (reference) fasted, 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
Adverse Event
|
1
|
2
|
|
Period 1
Withdrawal by Subject
|
0
|
2
|
|
Period 1
Positive Drug Screen
|
0
|
1
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
3
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=92 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
|
31 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: 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.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Reformulated OXY (Test)
n=85 Participants
Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=83 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
47.4 ng/mL
Standard Deviation 12.9
|
48.4 ng/mL
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: 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. Note:One subject in Period 2 was excluded from this PK analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Reformulated OXY (Test)
n=85 Participants
Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=82 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
454 ng*h/mL
Standard Deviation 116
|
480 ng*h/mL
Standard Deviation 120
|
PRIMARY outcome
Timeframe: Blood samples collected over 72-hour periodPopulation: 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. Note:One subject in period 2 was excluded from this PK analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Reformulated OXY (Test)
n=85 Participants
Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=82 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
|
453 ng*h/mL
Standard Deviation 116
|
477 ng*h/mL
Standard Deviation 119
|
Adverse Events
Reformulated OXY (Test)
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Original OxyContin® (OXY) (Reference)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reformulated OXY (Test)
n=87 participants at risk
Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=90 participants at risk
Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Social circumstances
Substance abuse (positive for cotinine and amphetamines)
|
1.1%
1/87 • Number of events 1 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/90 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were 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=87 participants at risk
Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=90 participants at risk
Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.2%
8/87 • Number of events 8 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
7.8%
7/90 • Number of events 10 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
3/87 • Number of events 3 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
7.8%
7/90 • Number of events 7 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
General disorders
Fatigue
|
12.6%
11/87 • Number of events 11 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
7.8%
7/90 • Number of events 7 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Headache
|
9.2%
8/87 • Number of events 9 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
12.2%
11/90 • Number of events 13 • Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution,or up to 30 days after last dose.All SAEs were followed until resolution or event/sequelae stabilized.
AEs were learned of through spontaneous reports, subject interview, or subject diaries.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60