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Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394224
First Posted: July 14, 2011
Last Update Posted: October 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Drug: Levetiracetam Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Maximum drug concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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 Outcome Measures:
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • Plasma concentration at the end of infusion (C15' ) [ Time Frame: At 15 minutes after termination of the15-minutes infusion ]
  • Area under the curve from 0 to infinity (AUC) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • Mean resident time (MRT) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • Terminal elimination half-life(t1/2) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • First order terminal elimination rate constant (λz ) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • Total body clearance after oral administration (CL/F) or after IV infusion (CL) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]
  • Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ]

Enrollment: 25
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam IV Infusion (1500 mg) Drug: Levetiracetam
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
Other Name: E-Keppra
Experimental: Levetiracetam tablets (1500 mg) Drug: Levetiracetam
Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
Other Name: E-Keppra

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394224


Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01394224     History of Changes
Other Study ID Numbers: N01377
2011-000827-34 ( EudraCT Number )
First Submitted: July 12, 2011
First Posted: July 14, 2011
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by UCB Pharma:
Healthy volunteers
Japanese

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs