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Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets

NCT02106923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-03-09

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 combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Conditions

  • Healthy

Interventions

DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets

DRUG

10 mg Empagliflozin/1000 mg Metformin XR

Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

DRUG

1 tablet 10 mg Empagliflozin/3 tablets Metformin XR

Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets

DRUG

2 tablets 5 mg Empagliflozin/750 Metformin XR

Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets

DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets

DRUG

10 mg Empagliflozin/1000 mg Metformin XR

Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

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
2014-04-30
Primary Completion
2014-06-30
Completion
2014-07-31

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 NCT02106923 on ClinicalTrials.gov