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Trial record 70 of 89 for:    DESVENLAFAXINE

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01282801
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : March 8, 2011
Last Update Posted : March 8, 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 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Velafaxine 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 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.
Period Title: First Intervention
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Washout of 7 Days
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Second Intervention
Started 9 9
Completed 9 8
Not Completed 0 1
Reason Not Completed
Emesis During Critical Breakfast             0             1
Arm/Group Title Velafaxine 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 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 of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
18
 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 9 participants 9 participants 18 participants
Female
4
  44.4%
1
  11.1%
5
  27.8%
Male
5
  55.6%
8
  88.9%
13
  72.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 9 participants 9 participants 18 participants
9 9 18
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 9 participants 9 participants 18 participants
9 9 18
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
81.84  (37.59) 93.50  (37.73)
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1358.37  (766.51) 1383.57  (769.22)
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1596.83  (902.89) 1605.29  (910.77)
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
227.02  (48.08) 236.21  (57.37)
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5591.56  (1412.83) 5748.06  (1578.70)
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 Velafaxine 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 Extended-Release Capsules reference product dosed in either period.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
7945.58  (2636.77) 8102.12  (2769.50)
Time Frame Adverse event data was collected over the course of the study, which was approximately 2 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 Velafaxine 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 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.
All-Cause Mortality
Velafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Velafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Velafaxine Hydrochloride (Test) First Effexor® XR (Reference) First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/18 (66.67%)      14/18 (77.78%)    
General disorders     
Sore Throat * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Runny Nose * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Nausea * 1  4/18 (22.22%)  4 8/18 (44.44%)  9
Drowsiness * 1  1/18 (5.56%)  1 3/18 (16.67%)  3
Vomiting * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
High Blood Pressure * 1  5/18 (27.78%)  6 4/18 (22.22%)  4
Loose Stools * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Dizziness * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Difficulty Swallowing * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Tremors * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Redness of Arm * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Pain at Catheter Site * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Hot Flushes * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Swelling of Hand * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Swollen Arm * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Headache * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Bruising of Hand * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
Leukocytes in Urine * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Flatulence * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Difficulty Sleeping * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Back Pain * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
Delayed Ejaculation * 1  1/18 (5.56%)  1 1/18 (5.56%)  1
Protein in Urine * 1  0/18 (0.00%)  0 1/18 (5.56%)  1
*
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: NCT01282801     History of Changes
Other Study ID Numbers: 02205
First Submitted: January 24, 2011
First Posted: January 25, 2011
Results First Submitted: February 11, 2011
Results First Posted: March 8, 2011
Last Update Posted: March 8, 2011