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Drug Interaction Study of Digoxin and BI 10773

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01306175
First received: February 28, 2011
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.


Condition Intervention Phase
Healthy
 Drug: Digoxin plus BI 10773
Drug: Digoxin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Oral Dose of Digoxin (0.5 mg) When Administered Alone or in Combination With Multiple Oral Doses of BI 10773 (25 mg qd) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two-way Crossover Study)

Resource links provided by NLM:

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • AUC 0-inf of digoxin (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • Cmax of digoxin (maximum measured concentration of the analyte in plasma) [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz ) after single dose [ Time Frame: 96 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Digoxin alone (Reference)
Tablet, oral administration with 240 mL water
 Drug: Digoxin
Digoxin 0.5 mg as single dose
Experimental: Digoxin plus BI 10773 (Test)
Tablets, oral administration with 240 mL water
 Drug: Digoxin plus BI 10773
Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

-Healthy male and female subjects

Exclusion criteria:

-Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306175

Locations
Germany
1245.40.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01306175     History of Changes
Other Study ID Numbers: 1245.40, 2010-023170-40
Study First Received: February 28, 2011
Last Updated: September 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013