Trial Outcomes & Findings for Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions (NCT NCT01157169)
NCT ID: NCT01157169
Last Updated: 2020-01-18
Results Overview
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Blood samples collected over a 144 hour period.
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
Buprenorphine (Test) First
8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
|
Subutex® (Reference) First
8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
16
|
18
|
|
First Intervention
NOT COMPLETED
|
4
|
2
|
|
Washout of 10 Days
STARTED
|
16
|
18
|
|
Washout of 10 Days
COMPLETED
|
16
|
18
|
|
Washout of 10 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
18
|
|
Second Intervention
COMPLETED
|
16
|
17
|
|
Second Intervention
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Buprenorphine (Test) First
8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
|
Subutex® (Reference) First
8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Emesis Within 4 hrs of Administration
|
4
|
2
|
|
Second Intervention
Emesis Within 4 hrs of Administration
|
0
|
1
|
Baseline Characteristics
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Buprenorphine (Test) First
n=20 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
|
Subutex® (Reference) First
n=20 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=93 Participants
|
12 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Buprenorphine.
|
4.40 ng/mL
Standard Deviation 2.16
|
3.88 ng/mL
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t for Buprenorphine.
|
35.12 ng*h/mL
Standard Deviation 12.55
|
32.92 ng*h/mL
Standard Deviation 12.04
|
PRIMARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf for Buprenorphine.
|
37.19 ng*h/mL
Standard Deviation 13.39
|
35.73 ng*h/mL
Standard Deviation 13.93
|
SECONDARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax for Norbuprenorphine.
|
1.58 ng/mL
Standard Deviation 0.719
|
1.64 ng/mL
Standard Deviation 0.643
|
SECONDARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t for Norbuprenorphine.
|
45.34 ng*h/mL
Standard Deviation 18.72
|
47.58 ng*h/mL
Standard Deviation 17.91
|
SECONDARY outcome
Timeframe: Blood samples collected over a 144 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.
Outcome measures
| Measure |
Buprenorphine (Test)
n=33 Participants
8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
|
Subutex® (Reference)
n=33 Participants
8 mg Subutex® Sublingual Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf for Norbuprenorphine.
|
50.77 ng*h/mL
Standard Deviation 28.99
|
51.04 ng*h/mL
Standard Deviation 22.12
|
Adverse Events
Buprenorphine (Test) First
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Subutex® (Reference) First
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buprenorphine (Test) First
n=40 participants at risk
8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
|
Subutex® (Reference) First
n=40 participants at risk
8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
|
|---|---|---|
|
General disorders
Nausea
|
37.5%
15/40 • Number of events 15 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
20.0%
8/40 • Number of events 8 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Dizziness
|
20.0%
8/40 • Number of events 8 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
7.5%
3/40 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Headache
|
15.0%
6/40 • Number of events 6 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
15.0%
6/40 • Number of events 6 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Emesis
|
22.5%
9/40 • Number of events 9 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
7.5%
3/40 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
2/40 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER