Trial Outcomes & Findings for Lamotrigine 25 mg Chewable Tablets, Fasting (NCT NCT00838279)
NCT ID: NCT00838279
Last Updated: 2024-08-19
Results Overview
Bioequivalence basd on Cmax
COMPLETED
PHASE1
32 participants
Blood samples collected over 120 hour period
2024-08-19
Participant Flow
Participant milestones
| Measure |
Lamotrigine (Test) First
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® (Reference) First
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
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
16
|
16
|
|
Washout
COMPLETED
|
15
|
15
|
|
Washout
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
15
|
15
|
|
Second Intervention
COMPLETED
|
15
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lamotrigine (Test) First
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® (Reference) First
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
|
|---|---|---|
|
Washout
Protocol Violation
|
1
|
0
|
|
Washout
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Lamotrigine 25 mg Chewable Tablets, Fasting
Baseline characteristics by cohort
| Measure |
Lamotrigine (Test) First
n=16 Participants
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® (Reference) First
n=16 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.
Bioequivalence basd on Cmax
Outcome measures
| Measure |
Lamotrigine
n=29 Participants
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
|
Lamictal®
n=29 Participants
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
713.46 ng/mL
Standard Deviation 95.02
|
709.97 ng/mL
Standard Deviation 84.37
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Lamotrigine
n=29 Participants
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
|
Lamictal®
n=29 Participants
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
34541.03 ng*h/mL
Standard Deviation 14354.41
|
33498.85 ng*h/mL
Standard Deviation 12316.96
|
PRIMARY outcome
Timeframe: Blood samples collected over 120 hour periodPopulation: Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Lamotrigine
n=29 Participants
Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
|
Lamictal®
n=29 Participants
Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
28843.06 ng/mL
Standard Deviation 6866.12
|
28923.66 ng/mL
Standard Deviation 7355.31
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER