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Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide 50 mg group | Experimental | Lacosamide 50 mg tablet, once a day per os (po) |
|
| Placebo group matched with lacosamide 50 mg | Placebo Comparator | Placebo matched with lacosamide 50 mg tablet, po |
|
| Lacosamide 100 mg group | Experimental | Lacosamide 100 mg tablet, po |
|
| Placebo group matched with lacosamide 100 mg | Placebo Comparator | Placebo matched with lacosamide 100 mg tablet, po |
|
| Lacosamide 200 mg group | Experimental | Lacosamide 200 mg tablet, po |
|
| Placebo group matched with lacosamide 200 mg | Placebo Comparator | Placebo matched with lacosamide 200 mg tablet, po |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide 50 mg, tablet, once in the morning on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration | Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) | |
| Time of maximum plasma concentration (Tmax) during up to 9 days of administration | Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) | |
| Area under the plasma concentration curve (AUC) during up to 9 days of administration | Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) | |
| The fraction of drug excreted unchanged in urine (Fe) during up to 9 days of administration | Urine samples were collected 0 - 4 hr, 4 - 8 hr, 8 - 12 hr, 12 - 24 hr, 24 - 48 hr, 48 - 72 hr, 72 - 96 hr after administration at Day 1 and Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance (CL/F) | Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) | |
| Apparent volume of distribution (V/F) |
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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 |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 | Drug | Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 |
|
|
| Lacosamide | Drug | Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 |
|
|
| Placebo | Other | Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1. |
|
| Placebo | Other | Placebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 |
|
| Placebo | Other | Placebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 |
|
| Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |