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Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers

NCT02102932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-09-24

Study results available
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Summary

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Conditions

  • Healthy

Interventions

DRUG

5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin/850 mg metformin FDC

DRUG

12.5 mg empagliflozin

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

DRUG

12.5 mg empagliflozin

10mg empagliflozin tablet and 2.5 mg empagliflozin tablet

DRUG

850 mg metformin

850mg metformin tablet

DRUG

5 mg empagliflozin

5 mg empagliflozin

DRUG

5 mg empagliflozin

5 mg empagliflozin

DRUG

850 mg metformin

850 mg metformin

DRUG

12.5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin/850 mg metformin FDC

DRUG

12.5 mg empagliflozin/500 mg metformin FDC

12.5 mg empagliflozin/500 mg metformin FDC

DRUG

5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin FDC

DRUG

500 mg metformin

500 mg metformin

DRUG

500 mg metformin

500 mg metformin

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
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • China

Study Locations

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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 NCT02102932 on ClinicalTrials.gov