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Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

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ClinicalTrials.gov Identifier: NCT01764945
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 201335 (Reference) Drug: BI 201335 (Test) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
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)
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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 (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



Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.




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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


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

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 Posted: January 10, 2013    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Pharmaceutical Solutions