Trial Outcomes & Findings for A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities (NCT NCT01101308)
NCT ID: NCT01101308
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
55 participants
Primary outcome timeframe
Blood samples collected over 72-hour period
Results posted on
2010-05-25
Participant Flow
Study start date: 09-JUL-2008 to end date: 20-Aug-2008, at 1 site in the US (Madison, WI)
124 screened; 69 screen failures; 0 withdrew; 55 randomized and received study drug; 4 terminated early; 51 completed.
Participant milestones
| Measure |
Reformulated OXY 10 mg (Totowa) (Test) First
Reformulated OXY 10-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. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
|
Reformulated OXY 10 mg (Wilson) (Reference) First
Reformulated OXY 10-mg tablet Wilson, NC (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
|
27
|
28
|
|
Period 1
COMPLETED
|
24
|
27
|
|
Period 1
NOT COMPLETED
|
3
|
1
|
|
Period 2
STARTED
|
24
|
27
|
|
Period 2
COMPLETED
|
24
|
27
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reformulated OXY 10 mg (Totowa) (Test) First
Reformulated OXY 10-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. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
|
Reformulated OXY 10 mg (Wilson) (Reference) First
Reformulated OXY 10-mg tablet Wilson, NC (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
Adverse Event
|
2
|
1
|
|
Period 1
Positive for cotinine
|
1
|
0
|
Baseline Characteristics
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Baseline characteristics by cohort
| Measure |
Randomized Safety Population
n=55 Participants
Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
|
|---|---|
|
Age Continuous
Age
|
29 Years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 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 experiencing 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 (Totowa) (Test)
n=53 Participants
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=51 Participants
Reformulated OXY 10-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
|
9.81 ng/mL
Standard Deviation 2.32
|
9.58 ng/mL
Standard Deviation 2.52
|
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 experiencing 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 (Totowa) (Test)
n=53 Participants
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=51 Participants
Reformulated OXY 10-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)
|
112 ng*h/mL
Standard Deviation 26.5
|
111 ng*h/mL
Standard Deviation 24.3
|
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 experiencing 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 (Totowa) (Test)
n=53 Participants
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Reformulated OXY (Wilson) (Reference)
n=51 Participants
Reformulated OXY 10-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
|
111 ng*h/mL
Standard Deviation 26.4
|
110 ng*h/mL
Standard Deviation 24.2
|
Adverse Events
Reformulated OXY (Totowa) (Test)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Reformulated OXY (Wilson) (Reference)
Serious events: 0 serious events
Other events: 17 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 (Totowa) (Test)
n=52 participants at risk
Reformulated OXY 10-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 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Prerandomization
n=124 participants at risk
|
|---|---|---|---|
|
Social circumstances
Positive drug screen (cannabanoids)
|
0.00%
0/52 • 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%
0/54 • 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.
|
0.81%
1/124 • 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.
|
Other adverse events
| Measure |
Reformulated OXY (Totowa) (Test)
n=52 participants at risk
Reformulated OXY 10-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 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
|
Prerandomization
n=124 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.5%
6/52 • 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.
|
13.0%
7/54 • 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.
|
0.00%
0/124 • 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
Puncture Site Pain
|
7.7%
4/52 • 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.
|
3.7%
2/54 • 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.
|
0.00%
0/124 • 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
|
9.6%
5/52 • 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.
|
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.
|
0.00%
0/124 • 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
|
11.5%
6/52 • 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.
|
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.
|
0.00%
0/124 • 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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
4/52 • 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.
|
1.9%
1/54 • 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 learned of through spontaneous reports, subject interview, or subject diaries.
|
0.00%
0/124 • 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