Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin; Drug: Linagliptin; Drug: Linagliptin/Metformin FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084056

1288.11

2013-005144-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

Enrollment: 74 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects

Exclusion criteria

• Any relevant deviation from healthy condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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74 participants in 4 patient groups

FDC first, fasted

Experimental group

Description:

Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted

Treatment:

Drug: Linagliptin

Drug: Linagliptin/Metformin FDC

Drug: Metformin

Single tablets first, fasted

Experimental group

Description:

single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted

Treatment:

Drug: Linagliptin

Drug: Linagliptin/Metformin FDC

Drug: Metformin

FDC first, fed

Experimental group

Description:

Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed

Treatment:

Drug: Linagliptin

Drug: Linagliptin/Metformin FDC

Drug: Metformin

Single tablets first, fed

Experimental group

Description:

single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed

Treatment:

Drug: Linagliptin

Drug: Linagliptin/Metformin FDC

Drug: Metformin