Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment 1/Treatment 2

Group Type EXPERIMENTAL

Levetiracetam (Keppra)

Intervention Type DRUG

Test Drug :

Levetiracetam dry syrup

Reference Drug :

500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Treatment 2/Treatment 1

Group Type EXPERIMENTAL

Levetiracetam (Keppra)

Intervention Type DRUG

Test Drug :

Levetiracetam dry syrup

Reference Drug :

500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Interventions

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Levetiracetam (Keppra)

Test Drug :

Levetiracetam dry syrup

Reference Drug :

500 mg oral tablets of Levetiracetam. Frequency: Single Dose

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes