NCT03086382

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-27
• Primary completion: 2017-03-28
• Completion: 2017-03-28
• First posted: 2017-03-22
• Last updated: 2017-04-21

Locations

1 site across 1 country: China