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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 28, 2017

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • UCB Biopharma S.P.R.L.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Cares, Study Director, UCB (+1 877 822 9493)

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