A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

UCB Biopharma S.P.R.L.24 enrolled

Overview

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Lacosamide (LCM) tabletDRUG

Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Lacosamide (LCM) dry syrupDRUG

Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ep0059 001

London, United Kingdom