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Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764945
First Posted: January 10, 2013
Last Update Posted: July 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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.

Condition Intervention Phase
Healthy Drug: BI 201335 (Reference) Drug: BI 201335 (Test) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


  • 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.

  • 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.



Enrollment: 56
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (Test)
oral solution 3
Drug: BI 201335 (Reference)
soft gelatine capsule, oral administration
Drug: BI 201335 (Test)
oral solution 1
Drug: BI 201335 (Test)
oral solution 2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764945


Locations
Germany
1220.46.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01764945     History of Changes
Other Study ID Numbers: 1220.46
2012-000687-22 ( EudraCT Number: EudraCT )
First Submitted: January 8, 2013
First Posted: January 10, 2013
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Pharmaceutical Solutions