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Trial record 62 of 215 for:    Lamotrigine

Lamotrigine 25 mg Chewable Tablets, Non-Fasting

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ClinicalTrials.gov Identifier: NCT00838136
Recruitment Status : Completed
First Posted : February 6, 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: Lamotrigine 25 mg Chewable Tablets
Drug: Lamictal® 25 mg Chewable Tablets
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine (Test) First Lamictal® (Reference) First
Hide Arm/Group Description Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
Period Title: First Intervention
Started 16 16
Completed 16 16
Not Completed 0 0
Period Title: Second Intervention
Started 16 16
Completed 16 15
Not Completed 0 1
Arm/Group Title Lamotrigine (Test) First Lamictal® (Reference) First Total
Hide Arm/Group Description Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 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 16 participants 16 participants 32 participants
Female
2
  12.5%
0
   0.0%
2
   6.3%
Male
14
  87.5%
16
 100.0%
30
  93.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Caucasian 13 14 27
American Hispanic 3 0 3
Black 0 1 1
Asian 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 120 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 Lamotrigine Lamictal®
Hide Arm/Group Description:
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: ng/mL
612.45  (66.77) 604.85  (67.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Lamictal®
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 101.23
Confidence Interval 90%
99.88 to 102.60
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 120 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 Lamotrigine Lamictal®
Hide Arm/Group Description:
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
33783.02  (11635.51) 32950.62  (9855.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Lamictal®
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 101.87
Confidence Interval 90%
99.18 to 104.63
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 120 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 Lamotrigine Lamictal®
Hide Arm/Group Description:
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
28968.25  (6132.36) 28687.23  (5638.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Lamictal®
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 100.76
Confidence Interval 90%
98.60 to 102.97
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: NCT00838136     History of Changes
Other Study ID Numbers: 01304
First Submitted: February 5, 2009
First Posted: February 6, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: September 11, 2009