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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

Page last updated: August 23, 2015

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