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
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 April 16, 2014