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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Male Chinese Volunteers

Treatments: Drug: Lacosamide (LCM) solution for infusion; Drug: Lacosamide (LCM) tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03204474

SP1043

Details and patient eligibility

About

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.

Enrollment: 30 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 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment A - B

Experimental group

Description:

Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 200 mg administered as 2 oral tablets \[100 mg each\]), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion)

Treatment:

Drug: Lacosamide (LCM) tablet

Drug: Lacosamide (LCM) solution for infusion

Treatment B - A

Experimental group

Description:

Single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 200 mg administered as 2 oral tablets \[100 mg each\])

Treatment:

Drug: Lacosamide (LCM) tablet

Drug: Lacosamide (LCM) solution for infusion