Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01304329
First received: February 21, 2011
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.


Condition Intervention Phase
Healthy
Drug: BI 10773
Drug: simvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 10773 and Simvastatin After Single and Combined Administration - an Open-label, Randomised, Crossover Trial in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • pharmacokinetic interaction (AUC0-8, Cmax) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment A, reference
1 tablet BI 10773, oral administration with 240 ml water
Drug: BI 10773
Medium dose oral administration
Experimental: treatment B, reference
1 tablet simvastatin, oral administration with 240 ml water
Drug: simvastatin
Medium dose oral administration
Experimental: treatment C, test
1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
Drug: BI 10773
Medium dose oral administration
Drug: simvastatin
Medium dose oral administration

  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: NCT01304329

Locations
Germany
1245.63.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01304329     History of Changes
Other Study ID Numbers: 1245.63, 2010-023680-18
Study First Received: February 21, 2011
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014