Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01764945
First received: January 8, 2013
Last updated: October 31, 2013
Last verified: October 2013
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:
  • Maximum measured concentration of the analyte in plasma [ Time Frame: up to 6 days postdose ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: up to 6 days postdose ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point [ Time Frame: up to 6 days postdose ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01764945     History of Changes
Other Study ID Numbers: 1220.46, 2012-000687-22
Study First Received: January 8, 2013
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014