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Trial record 79 of 89 for:    DESVENLAFAXINE

Venlafaxine 25 mg Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00834964
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 18, 2009
Last Update Posted : September 15, 2009
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 25 mg Tablets
Drug: Effexor® 25 mg Tablets
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Venlafaxine (Test) First Effexor® (Reference) First
Hide Arm/Group Description Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
Period Title: First Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Washout: 7 Days
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Second Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Venlafaxine (Test) First Effexor® (Reference) First Total
Hide Arm/Group Description Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 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 15 participants 15 participants 30 participants
Female
1
   6.7%
2
  13.3%
3
  10.0%
Male
14
  93.3%
13
  86.7%
27
  90.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 15 participants 15 participants 30 participants
15 15 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Cmax - Maximum Observed Concentration - Venlafaxine in Plasma
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
38.11  (19.19) 39.91  (20.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 97.00
Confidence Interval 90%
92.72 to 101.49
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
327.78  (447.01) 309.75  (367.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 99.70
Confidence Interval 90%
94.74 to 104.92
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
273.66  (266.95) 273.03  (260.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 98.60
Confidence Interval 90%
93.46 to 104.02
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
4.Secondary Outcome
Title Cmax - O-Desmethylvenlafaxine in Plasma
Hide Description Informational Purposes Only
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
60.01  (22.83) 62.07  (22.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.29
Confidence Interval 90%
91.96 to 100.82
Estimation Comments Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.
5.Secondary Outcome
Title AUC0-inf - O-Desmethylvenlafaxine in Plasma
Hide Description Informational Purposes Only
Time Frame Blood samples collected over 24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1181.30  (478.25) 1123.62  (415.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 104.10
Confidence Interval 90%
100.08 to 108.29
Estimation Comments Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.
6.Secondary Outcome
Title AUC0-t - O-Desmethylvenlafaxine in Plasma
Hide Description Informational Purposes Only
Time Frame Blood samples collected over24 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from first 24 completed subjects were included in the statistical analysis per protocol.
Arm/Group Title Venlafaxine Effexor®
Hide Arm/Group Description:
Venlafaxine 25 mg Tablet (test) dosed in either period
Effexor® 25 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
844.35  (316.73) 838.37  (306.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Venlafaxine, Effexor®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 100.52
Confidence Interval 90%
97.30 to 103.84
Estimation Comments Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.
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.
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: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00834964     History of Changes
Other Study ID Numbers: 02354
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: July 6, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 15, 2009