Healthy Volunteers
Conditions
Keywords
Lacosamide, Bioequivalence, Dry Syrup
Brief summary
This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects
Interventions
Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet
DRUGLacosamide (LCM) dry syrup
Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is male and between 20 and 55 years of age (inclusive) * Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan) * Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug
Exclusion criteria
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study. * Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit. * Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit). * Subject has any clinically relevant ECG finding at the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | 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 curve from 0 to 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 |
Secondary
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vz/F) | 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 |
| Mean residence time (MRT) | 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 curve from zero up 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 |
| Terminal elimination half-life (t1/2) | 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 |
| First order terminal elimination rate constant (Lambda 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) | 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 total body clearance (CL/F) | 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 |
Countries
United Kingdom
Outcome results
None listed