A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

Conditions
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Healthy Male Chinese Volunteers

Intervention / Treatment
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* Drug: Lacosamide (LCM) tablet
* Drug: Lacosamide (LCM) solution for infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a Chinese male between 18 and 40 years of age Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used Exclusion Criteria: Clinically relevant out of range values for hematology and clinical chemistry variables abnormality in physical examination or vital signs ECG finding Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A - B<br>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) | Drug: Lacosamide (LCM) tablet<br>* Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg<br>* Other names: Vimpat;Drug: Lacosamide (LCM) solution for infusion<br>* Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion<br>* Other names: Vimpat;|
| Experimental: Treatment B - A<br>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]) | Drug: Lacosamide (LCM) tablet<br>* Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg<br>* Other names: Vimpat;Drug: Lacosamide (LCM) solution for infusion<br>* Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Bioequivalence, Intravenous solution, Tablet