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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 2 x 500 mg Metformin (Glumetza); Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC; Drug: 5 mg Linagliptin (Tradjenta); Drug: 5 mg Linagliptin/1000 mg Metformin FDC; Drug: 2x500 mg Metformin (Glumetza); Drug: 5 mg Linagliptin/1000mg Metformin FDC; Drug: 3x500 mg Metformin (Glumetza)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845077

1288.8

Details and patient eligibility

About

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin & metformin and the single tablets of linagliptin 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 6 patient groups

5 mg Linagliptin/1000 mg Metformin, fed

Active Comparator group

Description:

3 single tablets under fed conditions

Treatment:

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 2x500 mg Metformin (Glumetza)

5 mg Linagliptin/1500 mg Metformin FDC

Experimental group

Description:

2 FDC tablets under fasted conditions

Treatment:

Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC

5 mg Linagliptin/1500 mg Metformin

Active Comparator group

Description:

4 single tablets under fasted conditions

Treatment:

Drug: 3x500 mg Metformin (Glumetza)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

5 mg Linagliptin/1000 mg Metformin FDC

Experimental group

Description:

1 fixed dose combination(FDC) tablet under fasted conditions

Treatment:

Drug: 5 mg Linagliptin/1000mg Metformin FDC

5 mg Linagliptin/1000 mg Metformin

Active Comparator group

Description:

3 single tablets under fasted conditions

Treatment:

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 5 mg Linagliptin (Tradjenta)

Drug: 2 x 500 mg Metformin (Glumetza)

5mg Linagliptin/1000mg Metformin, FDCfed

Experimental group

Description:

1 FDC tablet under fed conditions

Treatment:

Drug: 5 mg Linagliptin/1000 mg Metformin FDC