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Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

NCT01764945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-07-31

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DRUG

BI 201335 (Reference)

soft gelatine capsule, oral administration

DRUG

BI 201335 (Test)

oral solution 3

DRUG

BI 201335 (Test)

oral solution 3

DRUG

BI 201335 (Test)

oral solution 2

DRUG

BI 201335 (Reference)

soft gelatine capsule, oral administration

DRUG

BI 201335 (Test)

oral solution 1

DRUG

BI 201335 (Test)

oral solution 1

DRUG

BI 201335 (Test)

oral solution 2

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764945 on ClinicalTrials.gov