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

NCT03086382 | Completed Phase 1

• 1 other identifier: SP1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Volunteers

Keywords

Lacosamide; Syrup; Bioequivalence; Tablet

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• 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 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

Study Arms (2)

Treatment A - B

EXPERIMENTAL

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; Drug: Lacosamide (LCM) syrup

Treatment B - A

EXPERIMENTAL

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

Interventions

Lacosamide (LCM) tablet DRUG

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

Treatment A - B; Treatment B - A

Lacosamide (LCM) syrup DRUG

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

Treatment A - B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Sp1001 001

Shanghai, China

Location

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• UCB Cares

  UCB (+1 877 822 9493)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 22, 2017
• Study Start: February 27, 2017
• Primary Completion: March 28, 2017
• Study Completion: March 28, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

CN (1)