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Drug Interaction Study of Digoxin and BI 10773

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306175
First Posted: March 1, 2011
Last Update Posted: June 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose ]
    Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.

  • Digoxin: Maximum Measured Concentration (Cmax) [ Time Frame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose ]
    Maximum measured concentration of digoxin, per period.


Secondary Outcome Measures:
  • Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose ]
    Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

-Healthy male and female subjects

Exclusion criteria:

-Any relevant deviation from healthy conditions

  Contacts and Locations
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): NCT01306175


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01306175     History of Changes
Other Study ID Numbers: 1245.40
2010-023170-40 ( EudraCT Number: EudraCT )
First Submitted: February 28, 2011
First Posted: March 1, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Digoxin
Empagliflozin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Hypoglycemic Agents