Skip to main content
OpenTrials
Completed

NCT Number: NCT03086382

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Male Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sp1001 001

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide (LCM) tablet

Drug

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Lacosamide (LCM) syrup

Drug

Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.