A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.

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 relevant

• 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