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Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

NCT01975220 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-03-08

Study results available
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Summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Conditions

  • Healthy

Interventions

DRUG

Empagliflozin/Metformin XR, FDC

Experimental: high dose empagliflozin/metformin XR, FDC tablet

DRUG

Empagliflozin/Metformin XR FDC

Experimental: low dose empagliflozin/metformin XR, FDC tablet

DRUG

25 mg Empagliflozin/1000 mg Metformin XR, FDC

Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1x empagliflozin/2x metformin XR tablets

DRUG

1 tablet Empagliflozin/3 tablets Metformin XR

Active Comparator: 1x empagliflozin/3x metformin XR tablets

DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1x empagliflozin/2x metformin XR tablets

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975220 on ClinicalTrials.gov