Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

July 3, 2015 updated by: Boehringer Ingelheim

Relative Bioavailability of BI 201335 (Capsule) Compared to Three Different Oral Solutions of BI 201335 Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Four-way Crossover Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Biberach, Germany
        • 1220.46.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 BI 201335
low dose
Drug: BI 201335 (Reference)
soft gelatine capsule, oral administration
Drug: BI 201335 (Test)
oral solution 3
Drug: BI 201335 (Test)
oral solution 2
Drug: BI 201335 (Test)
oral solution 1
Experimental: 2 BI 201335
high dose
Drug: BI 201335 (Reference)
soft gelatine capsule, oral administration
Drug: BI 201335 (Test)
oral solution 3
Drug: BI 201335 (Test)
oral solution 2
Drug: BI 201335 (Test)
oral solution 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-∞
Time Frame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.

Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.

The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.
Cmax
Time Frame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
AUC0-tz
Time Frame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.

Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.

The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 1220.46
  • 2012-000687-22 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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