A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-03-31

Brief Summary

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

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Related Clinical Trials

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

A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects

NCT03086382

Healthy Male Volunteers

COMPLETED PHASE1

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

NCT03204474

Healthy Male Chinese Volunteers

COMPLETED PHASE1

Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

NCT04939779

Healthy

COMPLETED PHASE1

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects

NCT01879423

Epilepsy

COMPLETED PHASE1

A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

NCT06312566

Healthy Study Participants

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Treatment A - B

Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), 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 100 mg given as dry syrup).

Group Type EXPERIMENTAL

Lacosamide (LCM) tablet

Intervention Type DRUG

Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Lacosamide (LCM) dry syrup

Intervention Type DRUG

Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Treatment B - A

Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), 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) 100 mg tablet).

Group Type EXPERIMENTAL

Lacosamide (LCM) tablet

Intervention Type DRUG

Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Lacosamide (LCM) dry syrup

Intervention Type DRUG

Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Interventions

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

Lacosamide (LCM) tablet

Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Intervention Type DRUG

Lacosamide (LCM) dry syrup

Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Subject is male and between 20 and 55 years of age (inclusive)
* Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
* Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug

Exclusion Criteria

* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
* Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit.
* Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit).
* Subject has any clinically relevant ECG finding at the Screening Visit.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes