At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
BI 1744 +3 moredrug
Likely dose
BI 1744 10 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Ketoconazole (Tablet) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
In Brief
A Phase 1 clinical trial evaluating BI 1744 and Ketoconazole for Healthy and Pulmonary Disease, Chronic Obstructive. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Pulmonary Disease, Chronic Obstructive
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedJun 2010
Primary CompletionAug 2010
TodayJul 2026
First PostedJun 30, 2010
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.0 years ago
Interventions
BI 1744drug
10 mcg solution for oral inhalation
BI 1744drug
10 mcg solution for oral inhalation
Ketoconazoledrug
400 mg tablet
Ketoconazoledrug
400 mg tablet