Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 42
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: medium single dose ofBI 10773/linagliptin FDC (Formulation A1) arm 2: medium single dose of mono components BI 10773/linagliptin arm 3: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal arm 4: medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Interventions: intervention 1: BI 10773/linagliptin intervention 2: BI 10773/linagliptin intervention 3: BI 10773/linagliptin SID intervention 4: BI 10773/linagliptin FDC
Intervention descriptions: intervention 1: medium single dose of BI 10773/linagliptin FDC (Formulation A1) intervention 2: medium single dose of BI 10773/linagliptin FDC (Formulation A3) intervention 3: medium single dose of mono components BI 10773/linagliptin intervention 4: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Protocol document: