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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 5 mg empagliflozin; Drug: 12.5 mg empagliflozin; Drug: 850 mg metformin; Drug: 12.5 mg empagliflozin/500 mg metformin FDC; Drug: 500 mg metformin; Drug: 5 mg empagliflozin/850 mg metformin FDC; Drug: 5 mg empagliflozin/500 mg metformin FDC; Drug: 12.5 mg empagliflozin/850 mg metformin FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102932

1276.23

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

12.5 mg empagliflozin/850 mg metformin

Experimental group

Description:

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

Treatment:

Drug: 12.5 mg empagliflozin/850 mg metformin FDC

Drug: 850 mg metformin

Drug: 12.5 mg empagliflozin

Drug: 12.5 mg empagliflozin

Drug: 850 mg metformin

5 mg empagliflozin/850 mg metformin

Experimental group

Description:

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

Treatment:

Drug: 5 mg empagliflozin

Drug: 5 mg empagliflozin/850 mg metformin FDC

Drug: 5 mg empagliflozin

Drug: 850 mg metformin

Drug: 850 mg metformin

12.5 mg empagliflozin/500 mg metformin

Experimental group

Description:

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

Treatment:

Drug: 500 mg metformin

Drug: 500 mg metformin

Drug: 12.5 mg empagliflozin

Drug: 12.5 mg empagliflozin

Drug: 12.5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin

Experimental group

Description:

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

Treatment:

Drug: 5 mg empagliflozin

Drug: 5 mg empagliflozin

Drug: 500 mg metformin

Drug: 500 mg metformin

Drug: 5 mg empagliflozin/500 mg metformin FDC