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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) syrup

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086382

SP1001

Details and patient eligibility

About

The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing in healthy Chinese male subjects.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment A - B

Experimental group

Description:

Single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions

Treatment:

Drug: Lacosamide (LCM) syrup

Drug: Lacosamide (LCM) tablet

Treatment B - A

Experimental group

Description:

Single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg) under fasting conditions

Treatment:

Drug: Lacosamide (LCM) tablet