Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 135585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01286571

2010-022697-14 (EudraCT Number)

1283.3

Details and patient eligibility

About

The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male subjects

Exclusion criteria

• 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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14 participants in 2 patient groups

BI 135585 (T)

Experimental group

Description:

single dose per subject as tablet formulation after high fat, high caloric meal

Treatment:

Drug: BI 135585

Drug: BI 135585

BI 135585 (R)

Experimental group

Description:

single dose per subject as tablet formulation after an overnight fast

Treatment:

Drug: BI 135585

Drug: BI 135585