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

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) syrup

• Registration Number: NCT03086382
• Lead Sponsor: UCB Biopharma S.P.R.L.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-22
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A - B	Lacosamide (LCM) tablet	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
Treatment A - B	Lacosamide (LCM) syrup	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
Treatment B - A	Lacosamide (LCM) tablet	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

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of Lacosamide (LCM)	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])	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)	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 Outcome Measures

Name	Time	Method
Terminal plasma elimination half-life (t1/2) of LCM	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	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	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	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.

Trial Locations

Locations (1)

Sp1001 001; 🇨🇳 Shanghai, China