A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT02972125
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- Brief Summary
This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B - A Lacosamide (LCM) tablet Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), 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) 100 mg tablet). Treatment A - B Lacosamide (LCM) dry syrup Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), 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 100 mg given as dry syrup). Treatment B - A Lacosamide (LCM) dry syrup Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), 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) 100 mg tablet). Treatment A - B Lacosamide (LCM) tablet Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), 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 100 mg given as dry syrup).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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
Trial Locations
- Locations (1)
Ep0059 001
🇬🇧London, United Kingdom