Drug Interaction Study of Digoxin and BI 10773
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)
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedResults Posted
Study results publicly available
June 17, 2014
CompletedJune 17, 2014
May 1, 2014
2 months
February 28, 2011
May 16, 2014
May 16, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.
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
Digoxin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of digoxin, per period.
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
Secondary Outcomes (1)
Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)
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
Study Arms (2)
Digoxin alone (Reference)
EXPERIMENTALTablet, oral administration with 240 mL water
Digoxin plus BI 10773 (Test)
EXPERIMENTALTablets, oral administration with 240 mL water
Interventions
Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects
You may not qualify if:
- Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1245.40.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Related Publications (1)
Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.
PMID: 23497760DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 1, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2011
Last Updated
June 17, 2014
Results First Posted
June 17, 2014
Record last verified: 2014-05