Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Levetiracetam (Drug); Levetiracetam (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Maximum drug concentration (Cmax)Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
Secondary outcome: Time to reach maximum plasma concentration (tmax)Plasma concentration at the end of infusion (C15' ) Area under the curve from 0 to infinity (AUC) Mean resident time (MRT) Terminal elimination half-life(t1/2) First order terminal elimination rate constant (λz ) Total body clearance after oral administration (CL/F) or after IV infusion (CL) Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy Japanese male and female volunteers with the age between 20 and 55 years old
Exclusion Criteria:
- 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.
Locations and Contacts
London, United Kingdom
Additional Information
Starting date: June 2011
Last updated: October 5, 2011
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