Trial Outcomes & Findings for Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions (NCT NCT01260896)
NCT ID: NCT01260896
Last Updated: 2011-02-21
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 36 hour period.
Results posted on
2011-02-21
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 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
|
10
|
12
|
|
First Intervention
NOT COMPLETED
|
2
|
0
|
|
Washout of 7 Days
STARTED
|
10
|
12
|
|
Washout of 7 Days
COMPLETED
|
10
|
12
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
12
|
|
Second Intervention
COMPLETED
|
10
|
12
|
|
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 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
Withdrawn Due to Emesis
|
2
|
0
|
Baseline Characteristics
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions
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 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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 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=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax of Venlafaxine.
|
124.75 ng/mL
Standard Deviation 47.01
|
117.69 ng/mL
Standard Deviation 49.23
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 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=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Venlafaxine.
|
2257.53 ng*h/mL
Standard Deviation 1459.51
|
2110.79 ng*h/mL
Standard Deviation 1363.13
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 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=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Venlafaxine.
|
2811.08 ng*h/mL
Standard Deviation 2240.01
|
2700.62 ng*h/mL
Standard Deviation 2106.47
|
SECONDARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
Cmax of O-Desmethylvenlafaxine.
|
192.33 ng/mL
Standard Deviation 90.85
|
167.42 ng/mL
Standard Deviation 78.56
|
SECONDARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of O-Desmethylvenlafaxine.
|
4539.33 ng*h/mL
Standard Deviation 2121.88
|
4174.60 ng*h/mL
Standard Deviation 1906.02
|
SECONDARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.
Outcome measures
| Measure |
Venlafaxine Hydrochloride (Test)
n=22 Participants
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
|
Effexor® XR (Reference)
n=22 Participants
150 mg Effexor® XR Capsules reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of O-Desmethylvenlafaxine.
|
6797.15 ng*h/mL
Standard Deviation 2558.92
|
6927.66 ng*h/mL
Standard Deviation 2660.13
|
Adverse Events
Venlafaxine Hydrochloride (Test) First
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Effexor® XR (Reference) First
Serious events: 0 serious events
Other events: 14 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 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
Vomiting
|
12.5%
3/24 • 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.
|
0.00%
0/24 • 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
Nausea
|
25.0%
6/24 • 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.
|
16.7%
4/24 • Number of events 4 • 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
High Potassium Levels
|
0.00%
0/24 • 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.
|
8.3%
2/24 • 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.
|
|
General disorders
Dizziness
|
8.3%
2/24 • 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.
|
12.5%
3/24 • 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
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 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.
|
16.7%
4/24 • Number of events 5 • 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
|
8.3%
2/24 • 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.
|
12.5%
3/24 • 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
Loose Stools
|
12.5%
3/24 • 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.
|
12.5%
3/24 • 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
|
8.3%
2/24 • 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.
|
4.2%
1/24 • Number of events 1 • 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
Heartburn
|
8.3%
2/24 • 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.
|
0.00%
0/24 • 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
Lost Appetite
|
16.7%
4/24 • Number of events 4 • 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.
|
25.0%
6/24 • 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
Delayed Ejaculation
|
4.2%
1/24 • Number of events 1 • 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.
|
8.3%
2/24 • 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