Clinical Trials Directory

Trials / Completed

CompletedNCT02447393

Phase 1 Study of Levocetirizine

A Single Blind, Randomized, Single Oral Dose Study to Compare the Oral Disposition of Levocetirizine When Given Alone (5mg) or as the Racemate (Cetirizine 10mg), and to Investigate the Safety and Tolerability and the Pharmacokinetics of Levocetirizine and Cetirizine, Following a Single Dose in Healthy Japanese Male Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
Male
Age
20 Years – 64 Years
Healthy volunteers
Accepted

Summary

This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.

Conditions

Interventions

TypeNameDescription
DRUGlevocetirizinelevocetirizine
DRUGcetirizinecetiridine
DRUGplaceboplacebo

Timeline

Start date
2008-03-18
Primary completion
2008-04-30
Completion
2008-04-30
First posted
2015-05-18
Last updated
2017-08-03

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT02447393. Inclusion in this directory is not an endorsement.