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Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

NCT01811953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-07-27

Study results available
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Summary

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Conditions

  • Healthy

Interventions

DRUG

Empagliflozin

medium dose oral administration

DRUG

Metformin

oral administration

DRUG

Empagliflozin

low dose of Empagliflozin oral administration

DRUG

Empagliflozin/Metformin

low dose of Empagliflozin

DRUG

Metformin

oral administration

DRUG

Empagliflozin/Metformin

medium dose of Empagliflozin oral administration

DRUG

Empagliflozin

medium dose oral administration

DRUG

Metformin

oral administration

DRUG

Empagliflozin/Metformin

medium dose of Empagliflozin oral administration

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
2013-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT01811953 on ClinicalTrials.gov