Human VolunteersPhase 1NCT01618903
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
A Phase 1 study testing Levetiracetam in people with Human Volunteers, run by UCB Pharma at 1 site in China.
Trial summary
The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Jul 2012
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese, age 18-40, weight ≥ 50 kg
- Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test
Who cannot join
- History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- History or presence of drug addiction or excessive use of alcohol
- Symptomatic or asymptomatic Orthostatic Hypotension at screening
- Current smokers and former smokers
- Heavy caffeine drinker
- History of frequent and severe headache
Show all 10Show fewer
- Any drug treatment
- Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
- Subjects on a controlled sodium diet
- Subject has made a blood donation or had a comparable blood loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers
The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.
Read the detailed description
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
- Conditions
- Human Volunteers
- Being tested
- Levetiracetam
- Keywords
- Keppra Levetiracetam intravenous, Oral tablets, Bioequivalence, Pharmacokinetics, Safety, Chinese healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.
LevetiracetamDrug
Also called Keppra
Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam iv infusion | Experimental | Levetiracetam intravenous (iv) 45 min infusion administered as one single dose. Receives: Drug: Levetiracetam |
| Levetiracetam oral tablet | Experimental | Levetiracetam oral tablet administered as one single dose. Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Area under the plasma drug concentration-time curve from 0 to infinity (AUC)
The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Maximum measured plasma concentration (Cmax)
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Secondary outcomes (8)
Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))
The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.
Measured: Pharmacokinetic samples were taken at 45 min after Levetiracetam administration
Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Terminal half-life of Levetiracetam (t1/2)
The terminal half-life associated with the terminal rate constant λ_z is calculated as: ln2/λ_z. λ_z is the first order rate constant of elimination.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Total body clearance after intravenous infusion of Levetiracetam (CL(iv))
The CL(iv) is calculated as:
CL=Dose of LEV/AUC.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))
The CL/F (tablet) is calculated as:
CL/F=Dose of LEV/AUC.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))
The volume of distribution after iv infusion is calculated as:
Vz=CL/λ_z, where CL is the total body clearance and λ_z the first order rate constant of elimination.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))
The apparent volume of distribution after oral administration is calculated as:
Vz/F= (CL/F)/λ_z.
Measured: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human VolunteersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01618903
- Sponsor's protocol ID
- N01362A
- Status last verified
- Aug 2012
- First submitted
- 11 Jun 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01618903
- Acronym / sponsor ID
- N01362A
- Conditions
- Human Volunteers
- Keywords
- Keppra Levetiracetam intravenous, Oral tablets, Bioequivalence, Pharmacokinetics, Safety, Chinese healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Jun 2012 (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 part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.
Detailed description
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam iv infusion | Experimental | Drug: LevetiracetamLevetiracetam intravenous (iv) 45 min infusion administered as one single dose. |
| Levetiracetam oral tablet | Experimental | Drug: LevetiracetamLevetiracetam oral tablet administered as one single dose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chinese, age 18-40, weight ≥ 50 kg
- Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test
Key exclusion criteria (10 listed)
- History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- History or presence of drug addiction or excessive use of alcohol
- Symptomatic or asymptomatic Orthostatic Hypotension at screening
- Current smokers and former smokers
- Heavy caffeine drinker
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 |
|---|---|---|
| LevetiracetamAlso: KeppraLevetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1. | Drug | Levetiracetam iv infusion |
| LevetiracetamAlso: KeppraLevetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet. | Drug | Levetiracetam oral tablet |
Primary outcome
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Area under the plasma drug concentration-time curve from 0 to infinity (AUC)
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.
Maximum measured plasma concentration (Cmax)
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
8 secondary outcomes
Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))
Time frame: Pharmacokinetic samples were taken at 45 min after Levetiracetam administration
Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Terminal half-life of Levetiracetam (t1/2)
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Total body clearance after intravenous infusion of Levetiracetam (CL(iv))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))
Time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
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 3 Aug 2012.
- Keppra IVLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 in people with Human Volunteers, run by UCB Pharma at 1 site in China.
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 2 inclusion and 10 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 3 Aug 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 China. 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?
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t)) (time frame: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration). 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 3 Aug 2012.