Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

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. Identifier: NCT00985348
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Levetiracetam (Keppra) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cmax (maximum plasma concentration) of Levetiracetam. [ Time Frame: 36 hours ]
  2. 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 ]
  3. AUC (Area under the curve extrapolated to infinity) of Levetiracetam [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. tmax (time of maximum plasma concentration) of Levetiracetam [ Time Frame: 36 hours ]
  2. λz (Terminal elimination rate constant) of Levetiracetam [ Time Frame: 36 hours ]
  3. t1/2 (Terminal elimination half-life) of Levetiracetam [ Time Frame: 36 hours ]
  4. MRT (Mean Residence Time) of Levetiracetam [ Time Frame: 36 hours ]
  5. CL/F (Apparent total body clearance) of Levetiracetam [ Time Frame: 36 hours ]
  6. Vz/F (Apparent volume of distribution) of Levetiracetam [ Time Frame: 36 hours ]

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00985348

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

Responsible Party: UCB Pharma Identifier: NCT00985348     History of Changes
Other Study ID Numbers: N01339
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by UCB Pharma:
Healthy volunteers
Healthy Subjects

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