Overview

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

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
UCB Pharma SA
Treatments:
Lacosamide
Criteria
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