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

April 20, 2017 updated by: UCB Biopharma S.P.R.L.

A Randomized, Open-Label, Single-Dose, 2-Period Crossover Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects

The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing in healthy Chinese male subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Sp1001 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject is a Chinese male between 18 and 40 years of age
  • Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
  • Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used

Exclusion Criteria:

Clinically significant

  • out of range values for hematology and clinical chemistry variables
  • abnormality in physical examination or vital signs
  • ECG finding Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment A - B
Single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions
Drug: Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
Drug: Lacosamide (LCM) syrup
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Experimental: Treatment B - A
Single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg) under fasting conditions
Drug: Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of Lacosamide (LCM)
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Terminal plasma elimination half-life (t1/2) of LCM
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Terminal elimination half-life of LCM, reported in hours, as determined via simple linear regression(slope=-z) of natural log (ln) concentration vs time for data points in the terminal phase of the concentration-time curve. t½ is calculated as ln(2)/z.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Time of observed Cmax (tmax) of LCM
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Time of observed Cmax will be obtained directly from the plasma concentration-time curves.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Apparent plasma clearance (CL/F) of LCM
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Apparent plasma clearance calculated as CL/F=Dose/AUC.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Apparent volume of distribution (Vz/F) of LCM
Time Frame: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Apparent volume of distribution, calculated as Vz/F=(CL/F)/z.
Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma S.P.R.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, UCB (+1 877 822 9493)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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