HealthyPhase 1NCT00985348
Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)
A Phase 1 study testing Levetiracetam (Keppra) in people with Healthy, run by UCB Pharma at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Levetiracetam (Keppra)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Oct 2009
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Levetiracetam (Keppra)
- Keywords
- Levetiracetam, Healthy volunteers, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam (Keppra)Drug
Also called Keppra
Test Drug :
Levetiracetam dry syrup
Reference Drug :
500 mg oral tablets of Levetiracetam. Frequency: Single Dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1/Treatment 2 | Experimental | Not described Receives: Drug: Levetiracetam (Keppra) |
| Treatment 2/Treatment 1 | Experimental | Not described Receives: Drug: Levetiracetam (Keppra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum plasma concentration) of Levetiracetam.
Measured: 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
Measured: 36 hours
AUC (Area under the curve extrapolated to infinity) of Levetiracetam
Measured: 36 hours
Secondary outcomes (6)
tmax (time of maximum plasma concentration) of Levetiracetam
Measured: 36 hours
λz (Terminal elimination rate constant) of Levetiracetam
Measured: 36 hours
t1/2 (Terminal elimination half-life) of Levetiracetam
Measured: 36 hours
MRT (Mean Residence Time) of Levetiracetam
Measured: 36 hours
CL/F (Apparent total body clearance) of Levetiracetam
Measured: 36 hours
Vz/F (Apparent volume of distribution) of Levetiracetam
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionOct 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985348
- Sponsor's protocol ID
- N01339
- Status last verified
- May 2012
- First submitted
- 18 Sep 2009
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects
- ClinicalTrials.gov ID
- NCT00985348
- Acronym / sponsor ID
- N01339
- Conditions
- Healthy
- Keywords
- Levetiracetam, Healthy volunteers, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Sep 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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1/Treatment 2 | Experimental | Drug: Levetiracetam (Keppra) |
| Treatment 2/Treatment 1 | Experimental | Drug: Levetiracetam (Keppra) |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 (Keppra)Also: KeppraTest Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose | Drug | Treatment 1/Treatment 2, Treatment 2/Treatment 1 |
Primary outcome
Cmax (maximum plasma concentration) of Levetiracetam.
Time frame: 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
Time frame: 36 hours
AUC (Area under the curve extrapolated to infinity) of Levetiracetam
Time frame: 36 hours
6 secondary outcomes
tmax (time of maximum plasma concentration) of Levetiracetam
Time frame: 36 hours
λz (Terminal elimination rate constant) of Levetiracetam
Time frame: 36 hours
t1/2 (Terminal elimination half-life) of Levetiracetam
Time frame: 36 hours
MRT (Mean Residence Time) of Levetiracetam
Time frame: 36 hours
CL/F (Apparent total body clearance) of Levetiracetam
Time frame: 36 hours
Vz/F (Apparent volume of distribution) of Levetiracetam
Time frame: 36 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 16 May 2012.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levetiracetam (Keppra) in people with Healthy, run by UCB Pharma at 1 site in United Kingdom.
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 3 inclusion and 5 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 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cmax (maximum plasma concentration) of Levetiracetam. (time frame: 36 hours). The study lists 3 primary outcomes in all. 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 16 May 2012.