Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Levetiracetam 750 mg Tablets Under Non-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: NCT00849485
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : August 4, 2009
Last Update Posted : September 11, 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: Levetiracetam
Drug: Keppra®
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levetiracetam (Test) First Keppra® (Reference) First
Hide Arm/Group Description Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
Period Title: First Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Washout: 7 Days
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Second Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Levetiracetam (Test) First Keppra® (Reference) First Total
Hide Arm/Group Description Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
22
 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 11 participants 11 participants 22 participants
Female
5
  45.5%
6
  54.5%
11
  50.0%
Male
6
  54.5%
5
  45.5%
11
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 11 participants 11 participants 22 participants
11 11 22
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Levetiracetam Keppra®
Hide Arm/Group Description:
Levetiracetam 750 mg Tablet (test) dosed in either period
Keppra® 750 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mcg/mL
19.635  (3.854) 20.054  (4.125)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levetiracetam, Keppra®
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 Geometric Test/Ref Ratio x 100
Estimated Value 98.0
Confidence Interval 90%
94.5 to 102
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)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Levetiracetam Keppra®
Hide Arm/Group Description:
Levetiracetam 750 mg Tablet (test) dosed in either period
Keppra® 750 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
186.758  (30.682) 186.899  (31.029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levetiracetam, Keppra®
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 Geometric Test/Ref Ratio x 100
Estimated Value 99.9
Confidence Interval 90%
97.6 to 102
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)
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Levetiracetam Keppra®
Hide Arm/Group Description:
Levetiracetam 750 mg Tablet (test) dosed in either period
Keppra® 750 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
176.267  (31.911) 174.729  (33.259)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levetiracetam, Keppra®
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 Geometric Test/Ref Ratio x 100
Estimated Value 101
Confidence Interval 90%
98.1 to 104
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
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: 1-866-3848-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00849485     History of Changes
Other Study ID Numbers: 50277
First Submitted: February 20, 2009
First Posted: February 24, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: September 11, 2009