Trial Outcomes & Findings for Levetiracetam 750 mg Tablets Under Non-Fasting Conditions (NCT NCT00849485)

NCT ID: NCT00849485

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 Non-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	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	11 Participants n=7 Participants	22 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 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=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	19.635 mcg/mL Standard Deviation 3.854	20.054 mcg/mL Standard Deviation 4.125

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=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)	186.758 mcg*h/mL Standard Deviation 30.682	186.899 mcg*h/mL Standard Deviation 31.029

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=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 the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	176.267 mcg*h/mL Standard Deviation 31.911	174.729 mcg*h/mL Standard Deviation 33.259

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: 1-866-3848-5525

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