Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lacosamide oral; Drug: Lacosamide infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986608

2012-003084-21 (EudraCT Number)

EP0036

Details and patient eligibility

About

This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

Enrollment: 26 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion criteria

• Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months
• Subject has a history (within 6 months) before screening visit of chronic alcohol and/or drug abuse and/or has smoked and/or has a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, or neurological disorders
• Subject has a history of suicide attempt or current active suicidal ideation
• Subject has experienced a myocardial infarction and/or made a blood donation or any other blood loss more than 400 ml in the last 3 months
• Subject is pregnant or nursing
• Subject is not healthy (eg, taking any drug treatments, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters and/or was positive for HIV, HBsAg, HCV)
• Subject has an excessive use of alcohol or/and cigarettes and/or caffeine and/or abnormal diet and/or has taken grapefruit or grapefruit drink within 7 days before intake of Investigational Medicinal Product (IMP)
• Subject has a clinically significant abnormality in the 12-lead Electrocardiogram (ECG)
• Subject is having clinically relevant drug hypersensitivity to any components of the investigational medicinal product

Trial design

26 participants in 3 patient groups

Lacosamide 30-minute iv

Experimental group

Description:

A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).

Treatment:

Drug: Lacosamide infusion

Lacosamide 60-minute iv

Experimental group

Description:

60-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).

Treatment:

Drug: Lacosamide infusion

Lacosamide oral tablet

Experimental group

Description:

Oral administration of Lacosamide (LCM) 200 mg (2 x 100 mg film-coated tablet) with 200 mL of water.

Treatment:

Drug: Lacosamide oral