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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: Lacosamide

Criteria

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.