NCT00926302CompletedNot Applicable
A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 26
- Primary Endpoint
- To assess the bioequivalence
Study Overview
Brief Summary
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
Detailed Description
This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- •Healthy adult male, aged between 20 and 40 years old.
- •Body Mass Index between 18.5 and 25 (inclusive).
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- •No significant deviation from normal biochemistry examination.
- •No significant deviation from normal hematology examination.
- •No significant deviation from normal urinalysis examination.
Exclusion Criteria
- •History of drug or alcohol abuse within the past year.
- •Medical history of severe drug allergy or sensitivity to analogous drug.
- •Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.
- •Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- •Ongoing peptic ulcer and constipation.
- •Planned vaccination during the time course of the study.
- •Taking any clinical investigation drug from 2 months prior to Period I dosing.
- •Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
- •Blood donation of more than 500 mL within the past 3 months.
- •A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
- •A positive test for HIV antibody.
Arms & Interventions
Test drug
Experimental
Levetiracetam one period
Intervention: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) (Drug)
Reference drug
Active Comparator
Keppra one period
Intervention: Keppra (Levetiracetam - USB SA Pharma Sector) (Drug)
Outcomes
Primary Outcomes
To assess the bioequivalence
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed ConditionsSeizuresNCT00827320Roxane Laboratories26
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 1g Under Fasted ConditionsSeizuresNCT00826722Roxane Laboratories30
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed ConditionsSeizuresNCT00826787Roxane Laboratories29
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting ConditionsSeizuresNCT00826865Roxane Laboratories27
Completed
Phase 1
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in ChineseHuman VolunteersNCT01618903UCB Pharma24