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The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male 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) 200 mg administered as 2 oral tablets [100 mg each]), 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 200 mg administered as intravenous infusion) |
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| Treatment B - A | Experimental | Single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion), 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) 200 mg administered as 2 oral tablets [100 mg each]) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide (LCM) tablet | Drug | Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of Lacosamide (LCM) | Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration. | 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 LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t]) | Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule. | 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 LCM plasma concentration-time curve extrapolated to infinity (AUC) | Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant. | 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 |
|---|---|---|
| Terminal plasma elimination half-life (t1/2) of LCM | Terminal elimination half-life of LCM, reported in hours, as determined via simple linear regression (slope=-z) of natural log (ln) concentration vs time for data points in the terminal phase of the concentration-time curve. t½ is calculated as ln(2)/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 |
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Inclusion Criteria:
Exclusion Criteria:
Clinically relevant
Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sp1043 001 | Shanghai | China |
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| Lacosamide (LCM) solution for infusion | Drug | Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion |
|
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| Time of observed Cmax (tmax) of LCM | Time of observed Cmax will be obtained directly from the plasma concentration-time curves. | 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 plasma clearance (CL/F) of LCM | Apparent plasma clearance calculated as CL/F=Dose/AUC. CL/F will be calculated for the oral tablet formulation only | 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 volume of distribution (Vz/F) of LCM | Apparent volume of distribution, calculated as Vz/F=(CL/F)/z. Vz/F will be calculated for the oral tablet formulation only | 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 |
| Plasma clearance (CL) of LCM | Plasma clearance, calculated as CL=Dose/AUC. CL will be calculated for the iv formulation only. | 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 |
| Volume of distribution (Vz) of LCM | Volume of distribution, calculated as Vz=CL/z. Vz will be calculated for the iv formulation only. | 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 |
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D004364 | Pharmaceutical Preparations |
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