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

Healthy Male Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086382
• Other study ID #: SP1001
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2017
• Last updated: April 20, 2017
• Start date: February 27, 2017
• Est. completion date: March 28, 2017

Study information

• Verified date: April 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
• Lacosamide (LCM) syrup
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup

Locations

Country	Name	City	State
China	Sp1001 001	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of Lacosamide (LCM)	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
Primary	Area under the LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])	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
Primary	Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)	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	Terminal plasma elimination half-life (t1/2) of LCM	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
Secondary	Time of observed Cmax (tmax) of LCM	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
Secondary	Apparent plasma clearance (CL/F) of LCM	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
Secondary	Apparent volume of distribution (Vz/F) of LCM	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