Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00985348
First received: September 18, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.


Condition Intervention Phase
Healthy
Drug: Levetiracetam (Keppra)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Cmax (maximum plasma concentration) of Levetiracetam. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • AUC (Area under the curve extrapolated to infinity) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax (time of maximum plasma concentration) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • λz (Terminal elimination rate constant) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • t1/2 (Terminal elimination half-life) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • MRT (Mean Residence Time) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • CL/F (Apparent total body clearance) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Vz/F (Apparent volume of distribution) of Levetiracetam [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1/Treatment 2 Drug: Levetiracetam (Keppra)

Test Drug :

Levetiracetam dry syrup

Reference Drug :

500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Other Name: Keppra
Experimental: Treatment 2/Treatment 1 Drug: Levetiracetam (Keppra)

Test Drug :

Levetiracetam dry syrup

Reference Drug :

500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Other Name: Keppra

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent dated and signed by subject.
  • Healthy male or female Japanese volunteer from the first generation, living outside of Japan for less than 10 years, age range 20 to 55 years inclusive.
  • Body Mass Index (BMI) between 18.0 and 28.0 kg/m² inclusive.

Exclusion Criteria:

  • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication.
  • History of drug addiction or presence of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake in excess of 21 units alcohol for male and 14 units alcohol for female; one unit alcohol equals one glass of beer or lager, a glass of wine or a measure of spirits), of psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
  • Heavy caffeine drinker (drinking >5 cups of coffee or equivalent, approximately 500mg of caffeine per day).
  • Smokers of more than 10 cigarettes per day or smokers not willing to abstain from smoking while in the clinic for each period.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00985348

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: NCT00985348     History of Changes
Other Study ID Numbers: N01339
Study First Received: September 18, 2009
Last Updated: May 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Levetiracetam
Healthy volunteers
Healthy Subjects

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 July 29, 2014