Healthy Male Volunteers
Conditions
Keywords
Lacosamide, Syrup, Bioequivalence, Tablet
Brief summary
The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing 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) syrup
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 significant * 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, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 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, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 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, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 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 |
|---|---|---|
| Terminal plasma elimination half-life (t1/2) of LCM | Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 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. |
| Apparent volume of distribution (Vz/F) of LCM | Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing | Apparent volume of distribution, calculated as Vz/F=(CL/F)/z. |
| Time of observed Cmax (tmax) of LCM | Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 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, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing | Apparent plasma clearance calculated as CL/F=Dose/AUC. |
Countries
China
Outcome results
None listed