Trial Outcomes & Findings for Levetiracetam 750 mg Tablets Under Fasting Conditions (NCT NCT00849862)
NCT ID: NCT00849862
Last Updated: 2009-09-11
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Blood samples collected over 36 hour period
Results posted on
2009-09-11
Participant Flow
Participant milestones
| Measure |
Levetiracetam (Test) First
Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
|
Keppra® (Reference) First
Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout: 7 Days
STARTED
|
11
|
11
|
|
Washout: 7 Days
COMPLETED
|
11
|
11
|
|
Washout: 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
11
|
|
Second Intervention
COMPLETED
|
11
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levetiracetam 750 mg Tablets Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Levetiracetam (Test) First
n=11 Participants
Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
|
Keppra® (Reference) First
n=11 Participants
Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
|
Total
n=22 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
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 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
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 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
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 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=22 Participants
Levetiracetam 750 mg Tablet (test) dosed in either period
|
Keppra®
n=22 Participants
Keppra® 750 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
21.625 mcg/mL
Standard Deviation 5.699
|
23.501 mcg/mL
Standard Deviation 6.247
|
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=22 Participants
Levetiracetam 750 mg Tablet (test) dosed in either period
|
Keppra®
n=22 Participants
Keppra® 750 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
186.097 mcg*h/mL
Standard Deviation 35.240
|
185.293 mcg*h/mL
Standard Deviation 29.845
|
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=22 Participants
Levetiracetam 750 mg Tablet (test) dosed in either period
|
Keppra®
n=22 Participants
Keppra® 750 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
|
173.932 mcg*h/mL
Standard Deviation 33.436
|
174.275 mcg*h/mL
Standard Deviation 31.177
|
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