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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003084-21 | EudraCT Number |
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This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide 30-minute iv | Experimental | A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial). |
|
| Lacosamide 60-minute iv | Experimental | 60-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial). |
|
| Lacosamide oral tablet | Experimental | Oral administration of Lacosamide (LCM) 200 mg (2 x 100 mg film-coated tablet) with 200 mL of water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide infusion | Drug | Strength: 10 mg/mL for infusion Form: solution for infusion Dosage: 200 mg, single dose Duration: 30-minute infusion or 60-minute infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) | |
| Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) | |
| Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide |
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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 |
|---|---|---|---|---|---|---|
| 001 | Harrow | Middlesex | 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 oral | Drug | Strength: 200 mg Form: film-coated tablet Dosage: 200 mg, single dose Duration: single oral intake |
|
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| Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Mean residence time (MRT) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Apparent total body clearance (CL/F) after oral administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Total body clearance (CL) after intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Apparent volume of distribution (Vz/F) after oral administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Volume of distribution (Vz) after intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |