Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Levetiracetam (Keppra)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum plasma concentration) of Levetiracetam.	36 hours
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	36 hours
AUC (Area under the curve extrapolated to infinity) of Levetiracetam	36 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax (time of maximum plasma concentration) of Levetiracetam	36 hours
λz (Terminal elimination rate constant) of Levetiracetam	36 hours
t1/2 (Terminal elimination half-life) of Levetiracetam	36 hours
MRT (Mean Residence Time) of Levetiracetam	36 hours
CL/F (Apparent total body clearance) of Levetiracetam	36 hours
Vz/F (Apparent volume of distribution) of Levetiracetam	36 hours

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Healthy volunteers; Healthy Subjects; Levetiracetam
• Additional Relevant MeSH Terms: Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N01339