Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Linagliptin; Drug: Linagliptin/metformin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581931

1288.20

2011-005423-41 (EudraCT Number)

Details and patient eligibility

About

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects

Exclusion criteria

1. 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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32 participants in 2 patient groups

Linagliptin/metformin

Experimental group

Description:

fixed dose combination tablet (FDC)

Treatment:

Drug: Linagliptin/metformin

Linagliptin and metformin

Experimental group

Description:

single tablets

Treatment:

Drug: Linagliptin

Drug: Metformin