NCT01986608

Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lacosamide infusion	Strength: 10 mg/mL for infusion Form: solution for infusion Dosage: 200 mg, single dose Duration: 30-minute infusion or 60-minute infusion
DRUG	Lacosamide oral	Strength: 200 mg Form: film-coated tablet Dosage: 200 mg, single dose Duration: single oral intake

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-11-18
• Last updated: 2014-09-12

Locations

1 site across 1 country: United Kingdom