Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam iv infusion | Experimental | Levetiracetam intravenous (iv) 45 min infusion administered as one single dose. |
|
| Levetiracetam oral tablet | Experimental | Levetiracetam oral tablet administered as one single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t)) | 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. | 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. | Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12)) | 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)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Shanghai | China |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Levetiracetam | Drug | Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet. |
|
|
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.
| Pharmacokinetic samples were taken at 45 min after Levetiracetam administration |
| Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax) | 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. | 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. | 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. | 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. | 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. | Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |