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To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam IV infusions in Japanese | Experimental | Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects |
|
| Levetiracetam IV infusions in Caucasian | Experimental | Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple 15-minute intravenous infusions of 1500 mg levetiracetam | Drug | Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration after a single dose (Cmax) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion | |
| Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t)) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion | |
| Area under the plasma concentration time curve from zero to infinity after a single dose (AUC) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion | |
| Body-weight normalized maximum plasma concentration after a single dose (Cmax) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion | |
| Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t)) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion | |
| Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion | |
| Maximum plasma concentration at steady state after multiple doses (Cmax,ss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve over a dosing interval, (AUCτ (τ = 12 hours)) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion | |
| Time to maximum plasma concentration after a single dose (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 01 | Tokyo | Japan |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Area under the curve over a dosing interval at steady state after multiple doses (AUCτss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| Terminal elimination half-life after a single dose (t1/2) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| First order terminal elimination rate constant after a single dose (λz) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| Total body clearance after a single dose (CL) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| Volume of distribution during terminal phase after a single dose (Vz) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| Mean residence time after a single dose (MRT) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion. |
| Time to maximum plasma concentration at steady state after multiple doses (tmax,ss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Total body clearance at steady state after multiple doses (CLss) | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion. |
| Linearity factor after multiple doses (LF) | LF = AUCτss / AUC | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion. |
| Accumulation ratio (RAUC) after multiple doses | RAUC = AUCτss / AUCτ | Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |