Trial Outcomes & Findings for Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study (NCT NCT01282814)
NCT ID: NCT01282814
Last Updated: 2011-03-08
Results Overview
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples collected over a 48 hour period.
Results posted on
2011-03-08
Participant Flow
Participant milestones
| Measure |
Venlafaxine Hydrochloride (Test) First
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
|
Effexor® XR (Reference) First
150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
3
|
|
Washout of 7 Days
STARTED
|
12
|
9
|
|
Washout of 7 Days
COMPLETED
|
10
|
9
|
|
Washout of 7 Days
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
10
|
9
|
|
Second Intervention
COMPLETED
|
10
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Venlafaxine Hydrochloride (Test) First
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
|
Effexor® XR (Reference) First
150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Emesis During Dosing Interval
|
0
|
3
|
|
Washout of 7 Days
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
Baseline characteristics by cohort
| Measure |
Venlafaxine Hydrochloride (Test) First
n=12 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
|
Effexor® XR (Reference) First
n=12 Participants
150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
|
Total
n=24 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
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 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
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 participants
n=93 Participants
|
12 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=19 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=19 Participants
150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax of Venlafaxine.
|
120.07 ng/mL
Standard Deviation 45.48
|
103.59 ng/mL
Standard Deviation 39.47
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=19 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=19 Participants
150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Venlafaxine.
|
1972.77 ng*h/mL
Standard Deviation 1425.56
|
1800.03 ng*h/mL
Standard Deviation 1270.77
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=19 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=19 Participants
150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Venlafaxine.
|
2163.77 ng*h/mL
Standard Deviation 1647.47
|
2065.50 ng*h/mL
Standard Deviation 1626.52
|
Adverse Events
Venlafaxine Hydrochloride (Test) First
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Effexor® XR (Reference) First
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Venlafaxine Hydrochloride (Test) First
n=24 participants at risk
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
|
Effexor® XR (Reference) First
n=24 participants at risk
150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
|
|---|---|---|
|
General disorders
Tachycardia
|
12.5%
3/24 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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
Nausea
|
29.2%
7/24 • Number of events 8 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
25.0%
6/24 • Number of events 8 • Adverse event data was collected over the course of the study, which was approximately 2 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
Jaw Stiffness
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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
High Blood Pressure
|
16.7%
4/24 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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
Drowsiness
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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
Loose Stools
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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
|
12.5%
3/24 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
4.2%
1/24 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 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
Bradycardia
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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
Vomiting
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
16.7%
4/24 • Number of events 4 • Adverse event data was collected over the course of the study, which was approximately 2 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
Hot Flushes
|
0.00%
0/24 • Adverse event data was collected over the course of the study, which was approximately 2 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.
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 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