Phase 1
N=56
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01764945 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: AUC0-∞ — 3960; 3400; 3350; 3420 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 201335 (Reference) (Drug); BI 201335 (Test) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-∞ |
3960; 3400; 3350; 3420; 15000; 13900 | — |
| PRIMARY Cmax |
86.4; 65.4; 64.0; 69.7; 625.0; 481.0 | — |
| PRIMARY AUC0-tz |
3020; 2600; 2520; 2550; 14200; 12900 | — |
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.
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01764945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.