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To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBB 515 BS after a standard breakfast | Experimental |
| |
| BIBB 515 BS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBB 515 BS | Drug |
| ||
| Standard breakfast (40 g fat) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analyte in plasma (Cmax) | Up to 48 hours after drug administration | |
| Time to reach maximum concentration of the analyte in plasma (tmax) | Up to 48 hours after drug administration | |
| Apparent terminal elimination half-life of the analyte in plasma (t1/2) | Up to 48 hours after drug administration | |
| Area under the concentration-time curve of the analyte in plasma at different time points (AUC) | Up to 48 hours after drug administration | |
| Total mean residence time of the analyte in the body (MRTtot) | Up to 48 hours after drug administration | |
| Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f) | Up to 48 hours after drug administration | |
| Apparent volume of distribution of the analyte during the terminal phase (Vz/f) | Up to 48 hours after drug administration | |
| Terminal rate constant of the analyte in plasma (λz) | Up to 48 hours after drug administration | |
| Number of patients with adverse events | Up to 48 hours after last drug administration | |
| Global clinical assessment by the investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018955 | CD36 Antigens |
| ID | Term |
|---|---|
| D010980 | Platelet Membrane Glycoproteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Other |
|
| Day 3 after last drug administration |
| D002241 |
| Carbohydrates |
| D050612 | Fatty Acid Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011956 | Receptors, Cell Surface |
| D011971 | Receptors, Immunologic |
| D051122 | Scavenger Receptors, Class B |
| D051116 | Receptors, Scavenger |
| D011973 | Receptors, LDL |
| D018110 | Receptors, Lipoprotein |