Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 201335 (Reference)
* Drug: BI 201335 (Test)
* Drug: BI 201335 (Test)
* Drug: BI 201335 (Test)
* Drug: BI 201335 (Reference)
* Drug: BI 201335 (Test)
* Drug: BI 201335 (Test)
* Drug: BI 201335 (Test)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male and female subjects Exclusion criteria: Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ | 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 | 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 | 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. |