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To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline) administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending or descending colon, or as particulate to the ascending colon
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 671800 HEA delayed release (enteric coated) tablet | Experimental |
| |
| BI 671800 HEA solution released in jejunum | Experimental | BI 671800 HEA solution in the Enterion® capsule released in the jejunum |
|
| BI 671800 HEA solution released in ascending colon | Experimental | BI 671800 HEA solution in the Enterion® capsule released in the ascending colon |
|
| BI 671800 HEA solution released in descending colon | Experimental | BI 671800 HEA solution in the Enterion® capsule released in the descending colon |
|
| BI 671800 HEA particulate released in ascending colon | Experimental | BI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 671800 HEA delayed release (enteric coated) tablet | Drug |
| ||
| BI 671800 HEA solution |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity) | Up to 24 hours after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point) | Up to 24 hours after drug administration | |
| tmax (time from dosing to the maximum concentration of BI 671800 in plasma) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
| BI 671800 HEA particulate | Drug |
|
| Up to 24 hours after drug administration |
| Cmax (the maximum concentration of BI 671800 in plasma) | Up to 24 hours after drug administration |
| λz (terminal rate constant in plasma) | Up to 24 hours after drug administration |
| t½ (terminal half-life of BI 671800 in plasma) | Up to 24 hours after drug administration |
| MRTpo (mean residence time of BI 671800 in the body after oral administration) | Up to 24 hours after drug administration |
| CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration) | Up to 24 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | Up to 24 hours after drug administration |
| tlag (time to first quantifiable plasma concentration) | Up to 24 hours after drug administration |
| Number of patients with clinical significant findings in physical examination | Up to 10 days after last drug administration |
| Number of patients with clinical significant findings in vital signs | Up to 10 days after last drug administration |
| Number of patients with clinical significant findings in 12-lead electrocardiogram (ECG) | Up to 10 days after last drug administration |
| Number of patients with clinical significant findings in clinical laboratory tests | Up to 10 days after last drug administration |
| Number of patients with adverse events | Up to 10 days after last drug administration |