Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Levetiracetam (Keppra)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00985348

N01339

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.