Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
Phase 1
Withdrawn
- Conditions
- Healthy
- Interventions
- Drug: BI 691751 fastedDrug: BI 691751 after high fat breakfast
- Registration Number
- NCT02175238
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 691751 fasted BI 691751 fasted single dose BI 691751 in fasted state BI 691751 after high fat breakfast BI 691751 after high fat breakfast single dose BI 691751 after a standardised high fat breakfast
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz) up to 480 hours Maximum measured concentration of the analyte in plasma and whole blood (Cmax) up to 480 hours
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf) up to 480 hours
Trial Locations
- Locations (1)
1334.28.01001 Boehringer Ingelheim Investigational Site
🇺🇸Madison, Wisconsin, United States