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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
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Condition or disease Intervention/treatment Phase
Healthy Pulmonary Disease, Chronic Obstructive Drug: BI 1744 Drug: Fluconazole Phase 1

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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'.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy male and female volunteers

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
1222.48.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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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
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors