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Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

NCT02028767 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-07-24

Study results available
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Summary

The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Empagliflozin 2.5 mg

Empagliflozin 2.5 mg tablet

DRUG

Empagliflozin 10 mg

Empagliflozin 10 mg tablet

DRUG

Metformin 500 mg

Metformin 500 mg tablet

DRUG

Empagliflozin/Metformin FDC

12.5 mg Empagliflozin / 500 mg Metformin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Canada

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 NCT02028767 on ClinicalTrials.gov