Text Size

Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01672788
First received: August 22, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.


Condition Intervention Phase
Healthy
 Drug: Empagliflozin
Drug: Empagliflozin + Metformin
Drug: Metformin
 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: Bioequivalence of Empagliflozin/Metformin (850 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours after drug intake ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: up to 72 hours after drug intake ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test 1
fixed dose combination tablet
 Drug: Empagliflozin + Metformin
fixed dose combination tablet (low)
Active Comparator: Reference 1
empagliflozin tablets and metformin tablet
 Drug: Empagliflozin
empagliflozin tablets and metformin tablet
Drug: Metformin
empagliflozin tablets and metformin tablet
Experimental: Test 2
fixed dose combination tablet
 Drug: Empagliflozin + Metformin
fixed dose combination tablet (low)
Active Comparator: Reference 2
empagliflozin tablet and metformin tablet
 Drug: Metformin
empagliflozin tablet and metformin tablet
Drug: Empagliflozin
empagliflozin tablet and metformin tablet

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672788

Locations
Germany
1276.7.1 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: NCT01672788     History of Changes
Other Study ID Numbers: 1276.7, 2012-002277-65
Study First Received: August 22, 2012
Last Updated: April 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013