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Levetiracetam 1000 mg Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00859521
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : August 25, 2009
Last Update Posted : August 25, 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 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levetiracetam (Test) First Keppra® (Reference) First
Hide Arm/Group Description Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
Period Title: First Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Washout
Started 15 15
Completed 15 14
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 15 14
Completed 15 14
Not Completed 0 0
Arm/Group Title Levetiracetam (Test) First Keppra® (Reference) First Total
Hide Arm/Group Description Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 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
7
  46.7%
4
  26.7%
11
  36.7%
Male
8
  53.3%
11
  73.3%
19
  63.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
White 12 14 26
Black 2 0 2
Asian 1 0 1
American Indian or Alaska Native 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
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 1000 mg Tablet (test) dosed in either period
Keppra® 1000 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mcg/mL
30.281  (7.756) 31.512  (8.837)
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 Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 96.7
Confidence Interval 90%
92.4 to 101
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 1000 mg Tablet (test) dosed in either period
Keppra® 1000 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
281.155  (49.732) 285.645  (50.480)
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 Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 98.4
Confidence Interval 90%
96.9 to 100
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 1000 mg Tablet (test) dosed in either period
Keppra® 1000 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
269.172  (47.012) 272.498  (48.078)
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 Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Geometric Means
Estimated Value 98.8
Confidence Interval 90%
97.2 to 100
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: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00859521     History of Changes
Other Study ID Numbers: 20-116-SA
First Submitted: March 9, 2009
First Posted: March 11, 2009
Results First Submitted: July 9, 2009
Results First Posted: August 25, 2009
Last Update Posted: August 25, 2009