DDI Between BI Empagliflozin (10773) and Verapamil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01276301
First received: January 12, 2011
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

DDI with verapamil


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 10773 Given Alone and Together With Verapamil - 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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
single dose BI 10773
Drug: BI 10773
single dose BI 10773
Active Comparator: Test
single dose BI 10773 + single dose verapamil
Drug: Verapamil
single dose verapamil
Drug: BI 10773
single dose BI 10773

  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: NCT01276301

Locations
Germany
1245.43.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01276301     History of Changes
Other Study ID Numbers: 1245.43, 2010-023059-27
Study First Received: January 12, 2011
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014