Trial Outcomes & Findings for A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets (NCT NCT01101191)
NCT ID: NCT01101191
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 a 72-hour period.
Results posted on
2010-05-25
Participant Flow
13-Aug-2007 (first Informed Consent Form signed) to 23-Oct-2007 (last subject last visit), conducted at 1 site in the US, (Honolulu, HI)
136 screened; 47 screen failures; 5 withdrew prior to randomization; 84 randomized; 4 terminated early; 80 completed.
Participant milestones
| Measure |
Reformulated OXY (Test)
Reformulated OXY 80-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.
|
Original OxyContin® (OXY) (Reference)
Original OxyContin® (OXY) 80-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.
|
|---|---|---|
|
Period 1
STARTED
|
42
|
42
|
|
Period 1
COMPLETED
|
40
|
40
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
|
Period 2
STARTED
|
40
|
40
|
|
Period 2
COMPLETED
|
40
|
40
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Test)
Reformulated OXY 80-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.
|
Original OxyContin® (OXY) (Reference)
Original OxyContin® (OXY) 80-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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Adverse Event
|
1
|
2
|
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
Age
|
29 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 72-hour period.Population: 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=78 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=73 Participants
Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
85.1 ng/mL
Standard Deviation 21.5
|
83.0 ng/mL
Standard Deviation 20.1
|
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=78 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=71 Participants
Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
966 ng*h/mL
Standard Deviation 269
|
989 ng*h/mL
Standard Deviation 243
|
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=78 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Original OxyContin® (OXY) (Reference)
n=72 Participants
Original OxyContin® (OXY) 80-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
|
964 ng*h/mL
Standard Deviation 269
|
981 ng*h/mL
Standard Deviation 243
|
Adverse Events
Reformulated OXY (Test)
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Original OxyContin® (OXY) (Reference)
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Prerandomization
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reformulated OXY (Test)
n=82 participants at risk
Reformulated OXY 80-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.
|
Original OxyContin® (OXY) (Reference)
n=82 participants at risk
Original OxyContin® (OXY) 80-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.
|
Prerandomization
n=136 participants at risk
|
|---|---|---|---|
|
Social circumstances
Positive drug test
|
0.00%
0/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.74%
1/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
Other adverse events
| Measure |
Reformulated OXY (Test)
n=82 participants at risk
Reformulated OXY 80-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.
|
Original OxyContin® (OXY) (Reference)
n=82 participants at risk
Original OxyContin® (OXY) 80-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.
|
Prerandomization
n=136 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.2%
10/82 • Number of events 15 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
18.3%
15/82 • Number of events 19 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
8/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
13.4%
11/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
|
General disorders
Fatigue
|
7.3%
6/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
8.5%
7/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Dizziness
|
11.0%
9/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
13.4%
11/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Headache
|
14.6%
12/82 • Number of events 17 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
23.2%
19/82 • Number of events 22 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
|
Nervous system disorders
Somnolence
|
2.4%
2/82 • Number of events 2 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
7.3%
6/82 • 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 collected through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/136 • 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 collected 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