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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

NCT02039700

Healthy

COMPLETED PHASE1

Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers

NCT02792829

Healthy Volunteers

COMPLETED PHASE1

Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules

NCT01948011

Healthy Male Volunteers

COMPLETED PHASE1

To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901

NCT06171880

Healthy Adult

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

NCT02044406

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lacosamide 30-minute iv

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

Group Type EXPERIMENTAL

Lacosamide infusion

Intervention Type DRUG

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Lacosamide 60-minute iv

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

Group Type EXPERIMENTAL

Lacosamide infusion

Intervention Type DRUG

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Lacosamide oral tablet

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

Group Type EXPERIMENTAL

Lacosamide oral

Intervention Type DRUG

Strength: 200 mg

Form: film-coated tablet

Dosage: 200 mg, single dose

Duration: single oral intake

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lacosamide infusion

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Intervention Type DRUG

Lacosamide oral

Strength: 200 mg

Form: film-coated tablet

Dosage: 200 mg, single dose

Duration: single oral intake

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vimpat Vimpat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes