Healthy Male Chinese Volunteers
Conditions
Keywords
Lacosamide, Bioequivalence, Intravenous solution, Tablet
Brief summary
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.
Interventions
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
DRUGLacosamide (LCM) solution for infusion
Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of Lacosamide (LCM) | 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 | Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration. |
| Area under the LCM plasma concentration-time curve from time zero up to the 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 | 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. |
| Area under the LCM plasma concentration-time curve extrapolated 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution (Vz/F) of LCM | 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, calculated as Vz/F=(CL/F)/z. Vz/F will be calculated for the oral tablet formulation only |
| Terminal plasma elimination half-life (t1/2) of LCM | 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 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. |
| Volume of distribution (Vz) of LCM | 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, calculated as Vz=CL/z. Vz will be calculated for the iv formulation only. |
| Plasma clearance (CL) of LCM | 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, calculated as CL=Dose/AUC. CL will be calculated for the iv formulation only. |
| Time of observed Cmax (tmax) of LCM | 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 will be obtained directly from the plasma concentration-time curves. |
| Apparent plasma clearance (CL/F) of LCM | 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 calculated as CL/F=Dose/AUC. CL/F will be calculated for the oral tablet formulation only |
Countries
China
Outcome results
None listed