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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000827-34 | EudraCT Number |
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The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam IV Infusion (1500 mg) | Experimental |
| |
| Levetiracetam tablets (1500 mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration (Cmax) | Multiple sampling from 0 to 36 hours following single dose | |
| Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t) | Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum plasma concentration (tmax) | Multiple sampling from 0 to 36 hours following single dose | |
| Plasma concentration at the end of infusion (C15' ) | At 15 minutes after termination of the15-minutes infusion |
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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 |
|---|---|---|---|---|---|---|
| London | United Kingdom |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Levetiracetam | Drug | Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose |
|
|
| Area under the curve from 0 to infinity (AUC) | Multiple sampling from 0 to 36 hours following single dose |
| Mean resident time (MRT) | Multiple sampling from 0 to 36 hours following single dose |
| Terminal elimination half-life(t1/2) | Multiple sampling from 0 to 36 hours following single dose |
| First order terminal elimination rate constant (λz ) | Multiple sampling from 0 to 36 hours following single dose |
| Total body clearance after oral administration (CL/F) or after IV infusion (CL) | Multiple sampling from 0 to 36 hours following single dose |
| Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz) | Multiple sampling from 0 to 36 hours following single dose |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |