Clinical trial NCT03086382: A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Lacosamide
Syrup
Bioequivalence
Tablet
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of Lacosamide (LCM)
timeFrame: 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
measure: Area under the LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])
timeFrame: 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
measure: Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)
timeFrame: 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:
measure: Terminal plasma elimination half-life (t1/2) of LCM
timeFrame: 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
measure: Time of observed Cmax (tmax) of LCM
timeFrame: 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
measure: Apparent plasma clearance (CL/F) of LCM
timeFrame: 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
measure: Apparent volume of distribution (Vz/F) of LCM
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sp1001 001
Study officials:
affiliation: UCB (+1 877 822 9493)
name: UCB Cares
role: STUDY_DIRECTOR
References: