Drug Interaction Study of Digoxin and BI 10773

May 16, 2014 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Biberach, Germany
        • 1245.40.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

-Healthy male and female subjects

Exclusion criteria:

-Any relevant deviation from healthy conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.40
  • 2010-023170-40 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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