Trial Outcomes & Findings for A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01099709)
NCT ID: NCT01099709
Last Updated: 2010-05-06
Results Overview
Bioeqivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
85 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2010-05-06
Participant Flow
03-Jan-2007(first study procedure) to 16-Mar-2007(last subject follow-up) at 1 site in the US(Honolulu, HI)
145 subjects screened; 48 screen failures; 12 alternates/early discontinuations; 85 randomized; 3 terminated early; 82 completed.
Participant milestones
| Measure |
Reformulated OXY (Test)
Reformulated OXY 10-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)
Original OxyContin® (OXY) 10-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.
|
|---|---|---|
|
Period 1
STARTED
|
42
|
43
|
|
Period 1
COMPLETED
|
41
|
41
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
41
|
41
|
|
Period 2
COMPLETED
|
41
|
41
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Test)
Reformulated OXY 10-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)
Original OxyContin® (OXY) 10-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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 1
Positive cotinine test
|
0
|
1
|
|
Period 1
Adverse Event
|
1
|
0
|
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=85 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
|
28 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 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.
Bioeqivalence based on Cmax.
Outcome measures
| Measure |
Reformulated OXY (Test)
n=79 Participants
Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=81 Participants
Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
14.2 ng/mL
Standard Deviation 2.99
|
13.6 ng/mL
Standard Deviation 2.75
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72-hour time 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=79 Participants
Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=81 Participants
Original OxyContin® (OXY) 10-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)
|
143 ng*h/mL
Standard Deviation 33.5
|
150 ng*h/mL
Standard Deviation 36.7
|
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=79 Participants
Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=81 Participants
Original OxyContin® (OXY) 10-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
|
142 ng*h/mL
Standard Deviation 33.4
|
149 ng*h/mL
Standard Deviation 36.6
|
Adverse Events
Reformulated OXY 10-mg Tablet (Fed)
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Original OxyContin® (OXY) 10-mg Tablet (Fed)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reformulated OXY 10-mg Tablet (Fed)
n=83 participants at risk
Reformulated OXY 10-mg tablet (fed) x 1 dose
|
Original OxyContin® (OXY) 10-mg Tablet (Fed)
n=84 participants at risk
Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.7%
13/83 • Number of events 14 • 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.
|
15.7%
13/83 • Number of events 14 • 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
|
13.3%
11/83 • 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.
|
7.1%
6/84 • 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.
|
|
Nervous system disorders
Headache
|
10.8%
9/83 • 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.
|
7.1%
6/84 • 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.
|
|
Nervous system disorders
Somnolence
|
9.6%
8/83 • 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.
|
4.8%
4/84 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60