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

NCT00419783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-04-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Faes Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Mark J Allison, MD · MDS Pharma Services (US)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00419783 on ClinicalTrials.gov