Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers - Full Text View

Purpose

The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.

Condition	Intervention	Phase
Healthy	Drug: BI 10773 25 mg Drug: Warfarin 25 mg Drug: Warfarin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Relative Bioavailability of Both BI 10773 and Warfarin and Pharmacodynamics of Warfarin After Co-administration Compared to Multiple Oral Doses of BI 10773 (25 mg qd) and a Single Oral Dose of Warfarin (25mg) Alone in Healthy Male Volunteers (an Open-label,Crossover, Clinical Phase I Study)

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

AUC(tau,ss) (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 13 days ] [ Designated as safety issue: No ]
C(max,ss) (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) of BI 10773. [ Time Frame: 13 days ] [ Designated as safety issue: No ]
AUC(0-infinity) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
C(max) (maximum measured concentration of the analyte in plasma) of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
time from dosing to the maximum concentration of the analyte in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
terminal rate constant in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
terminal half-life of the analyte in plasma of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
mean residence time of the analyte in the body after po administration of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
apparent clearance of the analyte in the plasma after extravascular administration of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: No ]
apparent volume of distribution during the terminal phase following an extravascular dose of warfarin [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
terminal half-life of the analyte in plasma of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
terminal half-life of the analyte in plasma at steady state of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
mean residence time of the analyte in the body at steady state after oral administration of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
apparent clearance of the analyte in the plasma after extravascular administration at steady state of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
apparent volume of distribution during the terminal phase at steady state following extravascular administration of BI 10773 [ Time Frame: 13 days ] [ Designated as safety issue: No ]
Pharmacodynamics: Prothrombin Time (PT) as International Normalised Ratio (INR) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	May 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 10773 25 mg 1 tablet 25 mg BI 10773 qd for 5 days	Drug: BI 10773 25 mg 25 mg BI 10773 qd for 12 days
Experimental: BI 10773 25 mg + Warfarin 25 mg 1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose	Drug: BI 10773 25 mg 25 mg BI 10773 qd for 5 days Drug: Warfarin 25 mg 25 mg Warfarin single dose
Active Comparator: Warfarin 25 mg 5 tablets 5 mg warfarin single dose	Drug: Warfarin 25 mg warfarin single dose with and without 50 mg BI 10773

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy male subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111331

Locations

Germany
1245.18.1 Boehringer Ingelheim Investigational Site
Biberach, Germany

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01111331 History of Changes
Other Study ID Numbers:	1245.18, 2009-018088-29
Study First Received:	April 26, 2010
Last Updated:	October 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013