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The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam iv infusion | Experimental | Levetiracetam intravenous (iv) infusion. |
|
| Placebo infusion | Placebo Comparator |
|
| 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 every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B). |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve over a dosing interval (AUCτ) | The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ. | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 |
| 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 36 hours after iv administration on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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|
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| Placebo | Other | 15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B). |
|
| Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin) |
| Pharmacokinetic samples were taken 36 hours after iv administration on Day 7 |
| Terminal half-life (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 36 hours after iv administration on Day 7 |
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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