Relative Bioavailability of Olodaterol and Fluconazole
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ClinicalTrials.gov Identifier: NCT01153724 |
Recruitment Status :
Completed
First Posted : June 30, 2010
Results First Posted : June 10, 2014
Last Update Posted : June 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Pulmonary Disease, Chronic Obstructive | Drug: BI 1744 Drug: Fluconazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study) |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Olodaterol |
Drug: BI 1744
10 mcg solution for oral inhalation |
Experimental: Olodaterol + Fluconazole |
Drug: BI 1744
10 mcg solution for oral inhalation Drug: Fluconazole 400 mg capsule |
- Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours 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.
- Maximum Concentration at Steady State (Cmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) 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.
- Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.
- Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.
- Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
- Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ]AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: First administration of trial medication until 6 days after last administration of trial medication ]Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
- Assessment of Tolerability by the Investigator [ Time Frame: End of period 1 and end of period 2 ]The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.

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Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Healthy male and female volunteers

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153724
Germany | |
1222.48.1 Boehringer Ingelheim Investigational Site | |
Berlin, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01153724 |
Other Study ID Numbers: |
1222.48 2010-018528-18 ( EudraCT Number: EudraCT ) |
First Posted: | June 30, 2010 Key Record Dates |
Results First Posted: | June 10, 2014 |
Last Update Posted: | June 10, 2014 |
Last Verified: | May 2014 |
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