Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 201335 (Test); Drug: BI 201335 (Reference)

• Registration Number: NCT01764945
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2 BI 201335	BI 201335 (Test)	high dose
2 BI 201335	BI 201335 (Reference)	high dose
1 BI 201335	BI 201335 (Test)	low dose
1 BI 201335	BI 201335 (Reference)	low dose

Primary Outcome Measures

Name	Time	Method
AUC0-∞	-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.
Cmax	-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.
AUC0-tz	-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.

Trial Locations

Locations (1)

1220.46.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany