NCT00419783

A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine

A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.

Detailed description

This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	bilastine	20 mg tablets.
DRUG	Bilastine	100 mg (5 tablets of 20 mg)
DRUG	Bilastine & Ketoconazole	1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
DRUG	Moxifloxacin	1 capsule containing moxifloxacin 400 mg tablet
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2007-01-09
• Last updated: 2012-04-05

Locations

1 site across 1 country: United States