Healthy
Conditions
Brief summary
The objective of this trial is to assess the effect of BI 3000202 on the pharmacokinetics of rosuvastatin and digoxin given as a cocktail.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants cross over from reference treatment (R) to test treatment (T) (two periods, fixed sequence).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure BP, pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 55 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg / m\^2 (inclusive) * Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial * Further inclusion criteria apply.
Exclusion criteria
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 7 |
| Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 7 |
| Maximum measured concentration of rosuvastatin in plasma (Cmax) | Up to Day 7 |
| Maximum measured concentration of digoxin in plasma (Cmax) | Up to Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 7 |
| Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 7 |
Countries
Germany
Outcome results
None listed