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Relative Bioavailability of Olodaterol and Fluconazole

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01153724
First received: June 29, 2010
Last updated: May 4, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
Pulmonary Disease, Chronic Obstructive
 Drug: BI 1744
Drug: Fluconazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

Drug Information available for: Fluconazole
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The objective of the current study is to investigate whether and to what extent the CYP 2C9 inhibitor fluconazole affects systemic exposure to olodaterol [ Time Frame: whole study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The assessment of safety and tolerability of olodaterol and fluconazole upon co-administration is secondary objective of the present trial [ Time Frame: whole study ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: May 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1744 10 mcg
solution for oral inhalation
 Drug: BI 1744
10 mcg solution for oral inhalation
Drug: Fluconazole
400 mg capsule
Experimental: Fluconazole 400 mg
capsule (800 mg loading dose)
 Drug: BI 1744
10 mcg solution for oral inhalation
Drug: Fluconazole
400 mg capsule

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy male and female volunteers

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153724

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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01153724     History of Changes
Other Study ID Numbers: 1222.48, 2010-018528-18
Study First Received: June 29, 2010
Last Updated: May 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013