Trial Outcomes & Findings for A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01100086)
NCT ID: NCT01100086
Last Updated: 2010-05-25
Results Overview
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2010-05-25
Participant Flow
02-Jan-2007 to 06-Mar-2007 at 1 site in the US (Madison, WI)
167 subjects screened; 83 screen failures; 84 randomized; 1 terminated early; 83 completed
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Period 1
STARTED
|
43
|
41
|
|
Period 1
COMPLETED
|
42
|
41
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
42
|
41
|
|
Period 2
COMPLETED
|
42
|
41
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=84 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
|
32 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 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.
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Outcome measures
| Measure |
Reformulated OXY (Test)
n=81 Participants
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)
n=81 Participants
Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
9.60 ng/mL
Standard Deviation 2.49
|
9.38 ng/mL
Standard Deviation 1.92
|
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.
AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.
Outcome measures
| Measure |
Reformulated OXY (Test)
n=81 Participants
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)
n=81 Participants
Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted 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)
|
110 ng*h/mL
Standard Deviation 25.0
|
114 ng*h/mL
Standard Deviation 28.6
|
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.
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.
Outcome measures
| Measure |
Reformulated OXY (Test)
n=81 Participants
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)
n=81 Participants
Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted 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
|
110 ng*h/mL
Standard Deviation 25.0
|
113 ng*h/mL
Standard Deviation 28.3
|
Adverse Events
Reformulated OXY (Test)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Original OxyContin® (OXY) (Reference)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reformulated OXY (Test)
n=84 participants at risk
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)
n=83 participants at risk
Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.1%
11/84 • 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.
|
12.0%
10/83 • 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.
|
|
Nervous system disorders
Dizziness
|
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.
|
1.2%
1/83 • 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.
|
|
Nervous system disorders
Headache
|
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.
|
3.6%
3/83 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60