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Trials / Completed

CompletedNCT02972125

A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study to Investigate the Bioequivalence Between Lacosamide Tablet and Dry Syrup in Healthy Male Japanese Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
24 (actual)
Sponsor
UCB Biopharma S.P.R.L. · Industry
Sex
Male
Age
20 Years – 55 Years
Healthy volunteers
Accepted

Summary

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Conditions

Interventions

TypeNameDescription
DRUGLacosamide (LCM) tabletTreatment A: Single dose of Lacosamide (LCM) 100 mg tablet
DRUGLacosamide (LCM) dry syrupTreatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Timeline

Start date
2016-11-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2016-11-23
Last updated
2017-03-10

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02972125. Inclusion in this directory is not an endorsement.

A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects (NCT02972125) · Clinical Trials Directory