HealthyNCT00926302
A Bioequivalence Study of Levetiracetam Versus Keppra
A study testing Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) and Keppra (Levetiracetam - USB SA Pharma Sector) in people with Healthy, run by Tri-Service General Hospital (TSGH).
Trial summary
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) and Keppra (Levetiracetam - USB SA Pharma Sector)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
Read the 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.
- Conditions
- Healthy
- Being tested
- Levetiracetam (Lotus Pharmaceutical Co.,Ltd.), Keppra (Levetiracetam - USB SA Pharma Sector)
- Keywords
- The bioequivalence of Levetiracetam vs. Keppra, volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)Drug
Also called The test drug Levetiracetam is no brand name., Manufacturer:Lotus Pharmaceutical Co.,Ltd.
Levetiracetam 500mg/tablet Oral once
Keppra (Levetiracetam - USB SA Pharma Sector)Drug
Also called Keppra, Manufracturer:USB SA Pharma Sector
Levetiracetam 500mg/tablet oral once
| Study group | Role | What they receive |
|---|---|---|
| Test drug | Experimental | Levetiracetam one period Receives: Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) |
| Reference drug | Active comparator | Keppra one period Receives: Drug: Keppra (Levetiracetam - USB SA Pharma Sector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the bioequivalence
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Investigators
- I-Shin Shiah, M.D., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926302
- Sponsor's protocol ID
- MCPE08034M1
- Other IDs
- TSGHIRB097-02-006, C159
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00926302
- Acronym / sponsor ID
- MCPE08034M1
- Conditions
- Healthy
- Keywords
- The bioequivalence of Levetiracetam vs. Keppra, volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test drug | Experimental | Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)Levetiracetam one period |
| Reference drug | Active comparator | Drug: Keppra (Levetiracetam - USB SA Pharma Sector)Keppra one period |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)Also: The test drug Levetiracetam is no brand name., Manufacturer:Lotus Pharmaceutical Co.,Ltd.Levetiracetam 500mg/tablet Oral once | Drug | Test drug |
| Keppra (Levetiracetam - USB SA Pharma Sector)Also: Keppra, Manufracturer:USB SA Pharma SectorLevetiracetam 500mg/tablet oral once | Drug | Reference drug |
Primary outcome
To assess the bioequivalence
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Shin Shiah, M.D. principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) and Keppra (Levetiracetam - USB SA Pharma Sector) in people with Healthy, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the bioequivalence (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.