Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 10773/linagliptin; Drug: BI 10773/linagliptin SID; Drug: BI 10773/linagliptin FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189201

2010-019211-38 (EudraCT Number)

1275.3

Details and patient eligibility

About

The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison.

The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison.

An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

healthy male and female subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

BI 10773/linagliptin FDC SID

Experimental group

Description:

medium single dose ofBI 10773/linagliptin FDC (Formulation A1)

Treatment:

Drug: BI 10773/linagliptin

Drug: BI 10773/linagliptin

BI 10773/linagliptin SID

Experimental group

Description:

medium single dose of mono components BI 10773/linagliptin

Treatment:

Drug: BI 10773/linagliptin SID

BI 10773/linagliptin FDC

Experimental group

Description:

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Treatment:

Drug: BI 10773/linagliptin FDC

BI 10773/linagliptin

Experimental group

Description:

medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Treatment:

Drug: BI 10773/linagliptin

Drug: BI 10773/linagliptin