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To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1/Treatment 2 | Experimental |
| |
| Treatment 2/Treatment 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam (Keppra) | Drug | Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum plasma concentration) of Levetiracetam. | 36 hours | |
| AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam | 36 hours | |
| AUC (Area under the curve extrapolated to infinity) of Levetiracetam | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (time of maximum plasma concentration) of Levetiracetam | 36 hours | |
| λz (Terminal elimination rate constant) of Levetiracetam | 36 hours | |
| t1/2 (Terminal elimination half-life) of Levetiracetam |
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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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|
| 36 hours |
| MRT (Mean Residence Time) of Levetiracetam | 36 hours |
| CL/F (Apparent total body clearance) of Levetiracetam | 36 hours |
| Vz/F (Apparent volume of distribution) of Levetiracetam | 36 hours |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |