Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin Single Tablet; Drug: Linagliptin Single Tablet; Drug: Linagliptin/Metformin Combo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01383356

1288.19

Details and patient eligibility

About

The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.

Enrollment: 58 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: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Linagliptin/Metformin medium dosecombo

Experimental group

Description:

patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily

Treatment:

Drug: Linagliptin/Metformin Combo

Linagliptin plus Metformin medium dose

Active Comparator group

Description:

patient to receive two individual tablets: Linagliptin and Metformin (medium dose)

Treatment:

Drug: Linagliptin Single Tablet

Drug: Metformin Single Tablet