Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion
2 other identifiers
interventional
25
1 country
1
Brief Summary
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 6, 2011
October 1, 2011
3 months
July 12, 2011
October 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum drug concentration (Cmax)
Multiple sampling from 0 to 36 hours following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose
Secondary Outcomes (8)
Time to reach maximum plasma concentration (tmax)
Multiple sampling from 0 to 36 hours following single dose
Plasma concentration at the end of infusion (C15' )
At 15 minutes after termination of the15-minutes infusion
Area under the curve from 0 to infinity (AUC)
Multiple sampling from 0 to 36 hours following single dose
Mean resident time (MRT)
Multiple sampling from 0 to 36 hours following single dose
Terminal elimination half-life(t1/2)
Multiple sampling from 0 to 36 hours following single dose
- +3 more secondary outcomes
Study Arms (2)
Levetiracetam IV Infusion (1500 mg)
EXPERIMENTALLevetiracetam tablets (1500 mg)
EXPERIMENTALInterventions
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
Eligibility Criteria
You may qualify if:
- Healthy Japanese male and female volunteers with the age between 20 and 55 years old
You may not qualify if:
- Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject is pregnant or lactating female.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (1)
Unknown Facility
London, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 6, 2011
Record last verified: 2011-10