Drug Interaction Study of Digoxin and BI 10773

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01306175
First received: February 28, 2011
Last updated: May 16, 2014
Last verified: May 2014
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional 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
Study First Received: February 28, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014