Skip to main content
OpenTrials
Completed

NCT Number: NCT01306175

Drug Interaction Study of Digoxin and BI 10773

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1245.40.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Healthy male and female subjects

Exclusion criteria

-Any relevant deviation from healthy conditions

Treatment and study plan

Digoxin plus BI 10773

Drug

Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily

Digoxin

Drug

Digoxin 0.5 mg as single dose

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
First posted
Mar 1, 2011
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.