Trial Outcomes & Findings for A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01100320)
NCT ID: NCT01100320
Last Updated: 2010-05-11
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
88 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2010-05-11
Participant Flow
22-Jan-2007 (date first ICF signed) to 30-Mar-2007 (last subject follow-up) at 1 site in the US (Austin, TX)
174 subjects screened; 84 screen failures; 2 discontinued prior to dosing; 88 randomized and dosed; 14 terminated early; 74 completed.
Participant milestones
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 40-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) 40-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
|
43
|
45
|
|
Period 1
COMPLETED
|
38
|
38
|
|
Period 1
NOT COMPLETED
|
5
|
7
|
|
Period 2
STARTED
|
38
|
38
|
|
Period 2
COMPLETED
|
37
|
37
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Test) First
Reformulated OXY 40-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) 40-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
|
2
|
4
|
|
Period 1
Positive Drug Screen
|
1
|
1
|
|
Period 1
Adverse Event
|
2
|
2
|
|
Period 2
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=88 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
|
33 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 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=76 Participants
Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=80 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
62.0 ng/mL
Standard Deviation 16.5
|
61.5 ng/mL
Standard Deviation 12.3
|
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 AUC0-inf
Outcome measures
| Measure |
Reformulated OXY (Test)
n=76 Participants
Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=80 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fed, 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)
|
537 ng*h/mL
Standard Deviation 135
|
579 ng*h/mL
Standard Deviation 115
|
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 AUC0-t
Outcome measures
| Measure |
Reformulated OXY (Test)
n=76 Participants
Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=80 Participants
Original OxyContin® (OXY) 40-mg tablet (reference) fed, 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
|
535 ng*h/mL
Standard Deviation 134
|
577 ng*h/mL
Standard Deviation 115
|
Adverse Events
Reformulated OXY (Test)
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Original OxyContin® (OXY) (Reference)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reformulated OXY (Test)
n=81 participants at risk
Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=83 participants at risk
Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Social circumstances
Substance Abuse (positive for cocaine, amphetamine, and MDMA)
|
1.2%
1/81 • 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%
0/83 • 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=81 participants at risk
Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=83 participants at risk
Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
18.5%
15/81 • Number of events 16 • 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.
|
14.5%
12/83 • Number of events 12 • 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
|
8.6%
7/81 • 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.
|
4.8%
4/83 • Number of events 4 • 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
Dizziness
|
6.2%
5/81 • Number of events 6 • 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.
|
3.6%
3/83 • 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.
|
|
Nervous system disorders
Headache
|
9.9%
8/81 • 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.
|
3.6%
3/83 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60