NCT03204474

A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.

Conditions

• Healthy Male Chinese 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) solution for infusion	Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Timeline

• Start date: 2017-06-08
• Primary completion: 2017-07-28
• Completion: 2017-07-28
• First posted: 2017-07-02
• Last updated: 2017-08-02

Locations

1 site across 1 country: China