Healthy Volunteers
Conditions
Keywords
Lacosamide, Vimpat, Bioequivalence, Bioavailability, Japanese
Brief 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.
Interventions
DRUGLacosamide infusion
Strength: 10 mg/mL for infusion Form: solution for infusion Dosage: 200 mg, single dose Duration: 30-minute infusion or 60-minute infusion
DRUGLacosamide oral
Strength: 200 mg Form: film-coated tablet Dosage: 200 mg, single dose Duration: single oral intake
Sponsors
UCB Pharma SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
Secondary
| Measure | Time frame |
|---|---|
| Mean residence time (MRT) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Total body clearance (CL) after intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Apparent volume of distribution (Vz/F) after oral administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Volume of distribution (Vz) after intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Apparent total body clearance (CL/F) after oral administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
| Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) |
Countries
United Kingdom
Outcome results
None listed