Trial Outcomes & Findings for Levetiracetam 1000 mg Under Fasting Conditions (NCT NCT00859521)
NCT ID: NCT00859521
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Blood samples collected over 36 hour period
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Levetiracetam (Test) First
Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
|
Keppra® (Reference) First
Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
15
|
|
First Intervention
COMPLETED
|
15
|
15
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
15
|
15
|
|
Washout
COMPLETED
|
15
|
14
|
|
Washout
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
15
|
14
|
|
Second Intervention
COMPLETED
|
15
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Levetiracetam (Test) First
Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
|
Keppra® (Reference) First
Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
|
|---|---|---|
|
Washout
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Levetiracetam 1000 mg Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Levetiracetam (Test) First
n=15 Participants
Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
|
Keppra® (Reference) First
n=15 Participants
Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
|
Total
n=30 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Levetiracetam
n=29 Participants
Levetiracetam 1000 mg Tablet (test) dosed in either period
|
Keppra®
n=29 Participants
Keppra® 1000 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
30.281 mcg/mL
Standard Deviation 7.756
|
31.512 mcg/mL
Standard Deviation 8.837
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Levetiracetam
n=29 Participants
Levetiracetam 1000 mg Tablet (test) dosed in either period
|
Keppra®
n=29 Participants
Keppra® 1000 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
281.155 mcg*h/mL
Standard Deviation 49.732
|
285.645 mcg*h/mL
Standard Deviation 50.480
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Levetiracetam
n=29 Participants
Levetiracetam 1000 mg Tablet (test) dosed in either period
|
Keppra®
n=29 Participants
Keppra® 1000 mg 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)
|
269.172 mcg*h/mL
Standard Deviation 47.012
|
272.498 mcg*h/mL
Standard Deviation 48.078
|
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