Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule

• Registration Number: NCT01704846
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• 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: Male
• Target Recruitment: 60

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
Treatment sequence 2	BI 201335 NA 120 mg capsule	Reference - Test - Test - Reference
Treatment sequence 2	BI 201335 NA 40 mg capsule	Reference - Test - Test - Reference
Treatment sequence 1	BI 201335 NA 120 mg capsule	Test - Reference - Reference - Test
Treatment sequence 1	BI 201335 NA 40 mg capsule	Test - Reference - Reference - Test

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.; Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

Secondary Outcome Measures

Name	Time	Method
Time From Dosing to the Maximum Measured Concentration (Tmax)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Time from dosing to the maximum measured concentration of the analyte in plasma.; Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.
Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.; Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Mean Residence Time (MRTpo)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Terminal Rate Constant (λz)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Terminal Half-life (t1/2)	3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration	Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

Trial Locations

Locations (1)

1220.53.08101 Boehringer Ingelheim Investigational Site; 🇯🇵 Sumida-ku,Tokyo, Japan