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

NCT ID: NCT02102932

Last Updated: 2015-09-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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12.5 mg empagliflozin/850 mg metformin

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order

Group Type EXPERIMENTAL

12.5 mg empagliflozin

Intervention Type DRUG

10mg empagliflozin tablet and 2.5 mg empagliflozin tablet

850 mg metformin

Intervention Type DRUG

850mg metformin tablet

12.5 mg empagliflozin/850 mg metformin FDC

Intervention Type DRUG

12.5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin/850 mg metformin

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order

Group Type EXPERIMENTAL

5 mg empagliflozin/850 mg metformin FDC

Intervention Type DRUG

5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin

Intervention Type DRUG

5 mg empagliflozin

850 mg metformin

Intervention Type DRUG

850 mg metformin

12.5 mg empagliflozin/500 mg metformin

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order

Group Type EXPERIMENTAL

12.5 mg empagliflozin

Intervention Type DRUG

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

12.5 mg empagliflozin/500 mg metformin FDC

Intervention Type DRUG

12.5 mg empagliflozin/500 mg metformin FDC

500 mg metformin

Intervention Type DRUG

500 mg metformin

5 mg empagliflozin/500 mg metformin

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order

Group Type EXPERIMENTAL

5 mg empagliflozin

Intervention Type DRUG

5 mg empagliflozin

5 mg empagliflozin/500 mg metformin FDC

Intervention Type DRUG

5 mg empagliflozin/500 mg metformin FDC

500 mg metformin

Intervention Type DRUG

500 mg metformin

Interventions

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5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin/850 mg metformin FDC

Intervention Type DRUG

12.5 mg empagliflozin

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

Intervention Type DRUG

12.5 mg empagliflozin

10mg empagliflozin tablet and 2.5 mg empagliflozin tablet

Intervention Type DRUG

850 mg metformin

850mg metformin tablet

Intervention Type DRUG

5 mg empagliflozin

5 mg empagliflozin

Intervention Type DRUG

5 mg empagliflozin

5 mg empagliflozin

Intervention Type DRUG

850 mg metformin

850 mg metformin

Intervention Type DRUG

12.5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin/850 mg metformin FDC

Intervention Type DRUG

12.5 mg empagliflozin/500 mg metformin FDC

12.5 mg empagliflozin/500 mg metformin FDC

Intervention Type DRUG

5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin FDC

Intervention Type DRUG

500 mg metformin

500 mg metformin

Intervention Type DRUG

500 mg metformin

500 mg metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy male and female subjects

Exclusion Criteria

Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1276.23.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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1276.23

Identifier Type: -

Identifier Source: org_study_id

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