Status:
COMPLETED
A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine
Lead Sponsor:
Faes Farma, S.A.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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. Subje...
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 perio...
Eligibility Criteria
Inclusion
- Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results
Exclusion
- Clinically significant medical condition
- Clinically significant history of ECG abnormalities or family history of QTc interval syndrome
- Use of tobacco and/or nicotine products \>3 months prior to screening
- Use of any prescription medications within 14 days prior to screening
- Use of over the counter medications (including herbal products) within 7 days prior to screening
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00419783
Start Date
August 1 2006
End Date
December 1 2006
Last Update
April 5 2012
Active Locations (1)
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1
MDS Pharma Services
Phoenix, Arizona, United States, 85044