Trial Outcomes & Findings for Levetiracetam 1000 mg Under Non-Fasting Conditions (NCT NCT00859430)

NCT ID: NCT00859430

Last Updated: 2024-08-20

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: 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	11	11
First Intervention COMPLETED	11	10
First Intervention NOT COMPLETED	0	1
Second Intervention STARTED	11	10
Second Intervention COMPLETED	11	10
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
First Intervention Withdrawal by Subject	0	1

Baseline Characteristics

Levetiracetam 1000 mg Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Levetiracetam (Test) First n=11 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=11 Participants Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 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	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Levetiracetam n=21 Participants Levetiracetam 1000 mg Tablet (test) dosed in either period	Keppra® n=21 Participants Keppra® 1000 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	26.320 mcg/mL Standard Deviation 5.060	24.927 mcg/mL Standard Deviation 4.427

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Levetiracetam n=21 Participants Levetiracetam 1000 mg Tablet (test) dosed in either period	Keppra® n=21 Participants Keppra® 1000 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	261.018 mcg*h/mL Standard Deviation 45.320	263.968 mcg*h/mL Standard Deviation 40.007

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Levetiracetam n=21 Participants Levetiracetam 1000 mg Tablet (test) dosed in either period	Keppra® n=21 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)	249.260 mcg*h/mL Standard Deviation 44.183	252.523 mcg*h/mL Standard Deviation 39.858

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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