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Trial record 12 of 295 for:    Fluoxetine

90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01247285
Recruitment Status : Completed
First Posted : November 24, 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: Fluoxetine Hydrochloride
Drug: PROZAC WEEKLY®
Enrollment 26

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluoxetine Hydrochloride (Test) First Prozac® Weekly (Reference) First
Hide Arm/Group Description 90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period. 90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
Period Title: First Intervention
Started 13 13
Completed 13 13
Not Completed 0 0
Period Title: Washout of 28 Days
Started 13 13
Completed 13 13
Not Completed 0 0
Period Title: Second Intervention
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title Fluoxetine Hydrochloride (Test) First Prozac® Weekly (Reference) First Total
Hide Arm/Group Description 90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period. 90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
26
 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 13 participants 13 participants 26 participants
Female
6
  46.2%
4
  30.8%
10
  38.5%
Male
7
  53.8%
9
  69.2%
16
  61.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 13 participants 13 participants 26 participants
13 13 26
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Cmax of Fluoxetine.
Hide Description Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
75.32  (14.7) 69.86  (14.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 107.81
Confidence Interval (2-Sided) 90%
97.37 to 119.38
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 Fluoxetine.
Hide Description Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4148.71  (719.0) 4120.11  (614.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 100.69
Confidence Interval (2-Sided) 90%
92.90 to 109.14
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 Fluoxetine.
Hide Description Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4432.21  (1591.0) 4398.46  (1277.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 100.77
Confidence Interval (2-Sided) 90%
93.53 to 108.56
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 Norfluoxetine.
Hide Description Informational comparison of Cmax values for the metabolite Norfluoxetine.
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
35.11  (12.6) 33.47  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 104.88
Confidence Interval (2-Sided) 90%
98.53 to 111.64
Estimation Comments This analysis was for informational purposes only and was not used to establish bioequivalence.
5.Secondary Outcome
Title AUC0-t of Norfluoxetine.
Hide Description Informational comparison of AUC0-t values for the metabolite Norfluoxetine.
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
114575.21  (3451) 10849.08  (2978)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 105.64
Confidence Interval (2-Sided) 90%
99.97 to 111.56
Estimation Comments This analysis was for informational purposes only and was not used to establish bioequivalence.
6.Secondary Outcome
Title AUC0-inf of Norfluoxetine.
Hide Description Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.
Time Frame Blood samples collected over a 25 day period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description:
90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
90 mg Prozac® Weekly Capsules reference product dosed in first either period.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
13505.84  (5234) 13365.13  (6325)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoxetine Hydrochloride (Test), Prozac® Weekly (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 101.05
Confidence Interval (2-Sided) 90%
94.76 to 107.77
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 6 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 Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Hide Arm/Group Description 90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period. 90 mg Prozac® Weekly Capsules reference product dosed in either period.
All-Cause Mortality
Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluoxetine Hydrochloride (Test) Prozac® Weekly (Reference)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/26 (42.31%)      11/26 (42.31%)    
General disorders     
Headache * 1  6/26 (23.08%)  8 6/26 (23.08%)  8
Malaise * 1  2/26 (7.69%)  2 1/26 (3.85%)  1
Nausea * 1  3/26 (11.54%)  4 2/26 (7.69%)  2
Pharyngitis * 1  1/26 (3.85%)  1 4/26 (15.38%)  4
*
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
Name/Title: Associate Director, Biopharmaceutics
Organization: Teva Pharmaceuticals, USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT01247285     History of Changes
Other Study ID Numbers: R01-141
First Submitted: November 22, 2010
First Posted: November 24, 2010
Results First Submitted: January 24, 2011
Results First Posted: February 21, 2011
Last Update Posted: February 21, 2011