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)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER · EudraCT
interventional
32
1 country
1
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
Not reported
Date not reportedThis clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 29, 2010
Actual (reported)June 30, 2010
Actual (reported)August 2010
Actual (reported)April 30, 2014
Actual (reported)Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)
AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Day 8 of period 1 and day 14 of period 2
Maximum Concentration at Steady State (Cmax,ss)
Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Day 8 of period 1 and day 14 of period 2
Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
Day 8 of period 1 and day 14 of period 2
Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
Day 8 of period 1 and day 14 of period 2
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
Day 8 of period 1 and day 14 of period 2
Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)
Day 8 of period 1 and day 14 of period 2
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
First administration of trial medication until 6 days after last administration of trial medication
solution for oral inhalation
tablet
10 mcg solution for oral inhalation
10 mcg solution for oral inhalation
Contact the study team to confirm eligibility.
1222.47.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Boehringer Ingelheim
Boehringer Ingelheim
32 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
400 mg tablet
400 mg tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
August 2010
Actual (reported)Last Updated
April 30, 2014
Results First Posted
April 30, 2014
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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