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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01394224
First received: July 12, 2011
Last updated: October 5, 2011
Last verified: October 2011
  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:


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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: UCB Pharma
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 Pharma:
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 September 22, 2014