Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 1 tablet Empagliflozin/3 tablets Metformin XR; Drug: Empagliflozin/Metformin XR, FDC; Drug: Empagliflozin/Metformin XR FDC; Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975220

1276.13

Details and patient eligibility

About

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single tablets of empagliflozin and metformin when administered singularly.

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males or females
2. Age 18-50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria

Any deviation from healthy condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

High dose, fasted

Experimental group

Description:

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions

Treatment:

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

High dose, fed

Experimental group

Description:

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions

Treatment:

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

Drug: Empagliflozin/Metformin XR, FDC

Drug: 1 tablet Empagliflozin/2 tablets Metformin XR

Low dose, fasted

Experimental group

Description:

2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions

Treatment:

Drug: 1 tablet Empagliflozin/3 tablets Metformin XR

Drug: Empagliflozin/Metformin XR FDC