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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002462-31 | EudraCT Number |
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This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - B | Experimental | Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup). |
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| Treatment B - A | Experimental | Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide (LCM) tablet | Drug | Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing | |
| Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t)) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from zero up to infinity (AUC) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing | |
| Apparent total body clearance (CL/F) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0059 001 | London | United Kingdom |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Lacosamide (LCM) dry syrup | Drug | Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup |
|
| Apparent volume of distribution (Vz/F) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| Mean residence time (MRT) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| Time of observed Cmax (tmax) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| Terminal elimination half-life (t1/2) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| First order terminal elimination rate constant (Lambda z) | Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |