MDS Pharma Services
Phoenix, Arizona, 85044, United States
NCT Number: NCT00419783
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Phoenix, Arizona, 85044, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 mg tablets.
1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet
1 capsule containing moxifloxacin 400 mg tablet
Placebo tablets
Time frame: 4 days
Time frame: 4 days
Faes Farma, S.A.
Industry
A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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