A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects

• Status: Completed
• Trial end date: 2017-03-28
• Target enrollment: 0
• Participant gender: Male

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.

• 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 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