Trial Outcomes & Findings for To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities (NCT NCT01101321)
NCT ID: NCT01101321
Last Updated: 2015-11-18
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2015-11-18
Participant Flow
23-Jun-2008 (first Informed Consent Form signed) to 19-Aug-2008 (last subject last visit), at 1 site in the US (Honolulu, HI).
114 screened; 52 screen failures; 4 withdrew prior to randomization; 58 randomized; 8 terminated early; 50 completed.
Participant milestones
| Measure |
Reformulated OXY (Totowa) (Test) First
Reformulated OXY 80-mg tablet (Totowa)(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 (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
|
Reformulated OXY (Wilson) (Reference) First
Reformulated OXY 80-mg tablet (Wilson) (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 Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
|
|---|---|---|
|
Period 1
STARTED
|
30
|
28
|
|
Period 1
COMPLETED
|
26
|
24
|
|
Period 1
NOT COMPLETED
|
4
|
4
|
|
Period 2
STARTED
|
26
|
24
|
|
Period 2
COMPLETED
|
26
|
24
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reformulated OXY (Totowa) (Test) First
Reformulated OXY 80-mg tablet (Totowa)(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 (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
|
Reformulated OXY (Wilson) (Reference) First
Reformulated OXY 80-mg tablet (Wilson) (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 Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
1
|
|
Period 1
Adverse Event
|
3
|
3
|
Baseline Characteristics
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=58 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 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.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Reformulated OXY (Totowa) (Test)
n=47 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=50 Participants
Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
78.4 ng/mL
Standard Deviation 20.8
|
78.2 ng/mL
Standard Deviation 20.2
|
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.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Reformulated OXY (Totowa) (Test)
n=47 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=50 Participants
Reformulated OXY 80-mg tablet Wilson, NC (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)
|
846 ng*h/mL
Standard Deviation 223
|
850 ng*h/mL
Standard Deviation 191
|
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.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Reformulated OXY (Totowa) (Test)
n=47 Participants
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=50 Participants
Reformulated OXY 80-mg tablet Wilson, NC (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
|
843 ng*h/mL
Standard Deviation 223
|
848 ng*h/mL
Standard Deviation 191
|
Adverse Events
Reformulated OXY (Totowa) (Test)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Reformulated OXY (Wilson) (Reference)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reformulated OXY (Totowa) (Test)
n=54 participants at risk
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=54 participants at risk
Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
7.4%
4/54 • 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.
|
11.1%
6/54 • 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.
|
|
Gastrointestinal disorders
Nausea
|
20.4%
11/54 • 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.
|
13.0%
7/54 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
8/54 • Number of events 18 • 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.
|
14.8%
8/54 • 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 learned of through spontaneous reports, subject interview, or subject diaries.
|
|
General disorders
Fatigue
|
5.6%
3/54 • 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.
|
7.4%
4/54 • 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
|
14.8%
8/54 • 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.
|
11.1%
6/54 • 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.
|
|
Nervous system disorders
Headache
|
24.1%
13/54 • 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.
|
14.8%
8/54 • 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.
|
|
Nervous system disorders
Somnolence
|
20.4%
11/54 • 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.
|
9.3%
5/54 • Number of events 5 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
1/54 • 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.
|
7.4%
4/54 • 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
Clinical Leader
Purdue Pharma L.P.
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60