Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: pantoprazole 40 mg STADA; Drug: BI 113608; Drug: BI 113608 PIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703858

1314.3

2012-002537-11 (EudraCT Number)

Details and patient eligibility

About

The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

Enrollment: 15 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy male 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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15 participants in 5 patient groups

1 BI 113608

Active Comparator group

Description:

powder in the bottle for oral solution, oral administration with 240 mL water

Treatment:

Drug: BI 113608 PIB

2 BI 113608

Experimental group

Description:

conventional tablet formulation

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

3 BI 113608

Experimental group

Description:

conventional tablet formulation, fed

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

4 BI 113608

Experimental group

Description:

conventional tablet after pantoprazole administration

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: pantoprazole 40 mg STADA

Drug: BI 113608

5 BI 113608

Experimental group

Description:

conventional tablet formulation, fasted, 0:30 min before fat breakfast

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608