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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01394224
First received: July 12, 2011
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Maximum drug concentration (Cmax) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • Plasma concentration at the end of infusion (C15' ) [ Time Frame: At 15 minutes after termination of the15-minutes infusion ] [ Designated as safety issue: No ]
  • Area under the curve from 0 to infinity (AUC) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • Mean resident time (MRT) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • Terminal elimination half-life(t1/2) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • First order terminal elimination rate constant (λz ) [ Time Frame: Multiple sampling from 0 to 36 hours following single dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394224

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

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01394224     History of Changes
Other Study ID Numbers: N01377, 2011-000827-34
Study First Received: July 12, 2011
Last Updated: October 5, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Healthy volunteers
Japanese

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013