Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 201335 (Test); Drug: BI 201335 (Reference)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764945

1220.46

2012-000687-22 (EudraCT Number)

Details and patient eligibility

About

The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female 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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56 participants in 2 patient groups

1 BI 201335

Experimental group

Description:

low dose

Treatment:

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Reference)

Drug: BI 201335 (Reference)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

2 BI 201335

Experimental group

Description:

high dose

Treatment:

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Reference)

Drug: BI 201335 (Reference)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)

Drug: BI 201335 (Test)