Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

May 18, 2018

Primary Completion Date

September 17, 2018

Study Completion Date

September 17, 2018

Conditions
Rhinitis
Interventions
DRUG

Levocetirizine IRT 5 mg

Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).

DRUG

Levocetirizine ODT 5 mg

Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.

Trial Locations (1)

812-0025

GSK Investigational Site, Fukuoka

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Zensei Pharmaceutical Co., Ltd.

UNKNOWN

lead

GlaxoSmithKline

INDUSTRY

NCT03555890 - Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT) | Biotech Hunter | Biotech Hunter