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

NCT01672788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-31

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Empagliflozin

empagliflozin tablets and metformin tablet

DRUG

Empagliflozin + Metformin

fixed dose combination tablet (low)

DRUG

Metformin

empagliflozin tablets and metformin tablet

DRUG

Metformin

empagliflozin tablet and metformin tablet

DRUG

Empagliflozin + Metformin

fixed dose combination tablet (low)

DRUG

Empagliflozin

empagliflozin tablet and metformin 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
2012-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01672788 on ClinicalTrials.gov