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Trial record 71 of 89 for:    DESVENLAFAXINE

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01260896
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : February 21, 2011
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Venlafaxine Hydrochloride
Drug: Effexor® XR
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 12 12
Completed 10 12
Not Completed 2 0
Reason Not Completed
Withdrawn Due to Emesis             2             0
Period Title: Washout of 7 Days
Started 10 12
Completed 10 12
Not Completed 0 0
Period Title: Second Intervention
Started 10 12
Completed 10 12
Not Completed 0 0
Arm/Group Title Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
4
  33.3%
4
  33.3%
8
  33.3%
Male
8
  66.7%
8
  66.7%
16
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Cmax of Venlafaxine.
Hide Description Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
124.75  (47.01) 117.69  (49.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 106.84
Confidence Interval (2-Sided) 90%
100.54 to 113.54
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t of Venlafaxine.
Hide Description Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2257.53  (1459.51) 2110.79  (1363.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 105.34
Confidence Interval (2-Sided) 90%
100.37 to 110.55
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.
3.Primary Outcome
Title AUC0-inf of Venlafaxine.
Hide Description Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2811.08  (2240.01) 2700.62  (2106.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 103.12
Confidence Interval (2-Sided) 90%
97.80 to 108.73
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.
4.Secondary Outcome
Title Cmax of O-Desmethylvenlafaxine.
Hide Description Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
192.33  (90.85) 167.42  (78.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 114.21
Confidence Interval (2-Sided) 90%
109.29 to 119.35
Estimation Comments This analysis was for informational purposes only and was not used to establish bioequivalence.
5.Secondary Outcome
Title AUC0-t of O-Desmethylvenlafaxine.
Hide Description Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4539.33  (2121.88) 4174.60  (1906.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 108.26
Confidence Interval (2-Sided) 90%
104.84 to 111.79
Estimation Comments This analysis was for informational purposes only and was not used to establish bioequivalence.
6.Secondary Outcome
Title AUC0-inf of O-Desmethylvenlafaxine.
Hide Description Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.
Time Frame Blood samples collected over a 36 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Venlafaxine Hydrochloride (Test) Effexor® XR (Reference)
Hide Arm/Group Description:
150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
150 mg Effexor® XR Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
6797.15  (2558.92) 6927.66  (2660.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine Hydrochloride (Test), Effexor® XR (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 97.75
Confidence Interval (2-Sided) 90%
92.92 to 102.85
Estimation Comments This analysis was for informational purposes only and was not used to establish bioequivalence.
Time Frame Adverse event data was collected over the course of the study, which was approximately 3 weeks in duration.
Adverse Event Reporting Description 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.
 
Arm/Group Title Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Venlafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/24 (70.83%)      14/24 (58.33%)    
General disorders     
Vomiting * 1  3/24 (12.50%)  3 0/24 (0.00%)  0
Nausea * 1  6/24 (25.00%)  6 4/24 (16.67%)  4
High Potassium Levels * 1  0/24 (0.00%)  0 2/24 (8.33%)  2
Dizziness * 1  2/24 (8.33%)  2 3/24 (12.50%)  3
High Blood Pressure * 1  4/24 (16.67%)  4 4/24 (16.67%)  5
Headache * 1  2/24 (8.33%)  3 3/24 (12.50%)  3
Loose Stools * 1  3/24 (12.50%)  3 3/24 (12.50%)  3
Fatigue * 1  2/24 (8.33%)  2 1/24 (4.17%)  1
Heartburn * 1  2/24 (8.33%)  2 0/24 (0.00%)  0
Lost Appetite * 1  4/24 (16.67%)  4 6/24 (25.00%)  6
Delayed Ejaculation * 1  1/24 (4.17%)  1 2/24 (8.33%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Biopharmaceutics
Organization: Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260896     History of Changes
Other Study ID Numbers: 02204
First Submitted: December 14, 2010
First Posted: December 15, 2010
Results First Submitted: January 24, 2011
Results First Posted: February 21, 2011
Last Update Posted: February 21, 2011