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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-001356-42 |
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The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44370 TA tablet | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of BI 44370 BS in plasma) | 48 hours | |
| AUC0-2 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to 2 h after drug administration) | 48 hours | |
| AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity) | 48 hours | |
| tmax (time from dosing to maximum measured concentration) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to the time of the last quantifiable data point) | 48 hours | |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1246.21.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||||
| 1246.21.49001 Boehringer Ingelheim Investigational Site |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2) | 48 hours |
| λz (terminal rate constant in plasma) | 48 hours |
| t1/2 (terminal half-life of BI 44370 BS in plasma) | 48 hours |
| MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration) | 48 hours |
| CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration) | 48 hours |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | 48 hours |
| Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) | 48 hours |
| fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) | 48 hours |
| CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration) | 48 hours |
| Changes from baseline in Physical examination | 48 hours |
| Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR) | 48 hours |
| Changes from baseline in 12-lead electrocardiogram (ECG) | 48 hours |
| Occurrence of Adverse events (AEs) | 48 hours |
| Assessment of tolerability by investigator | 48 hours |
| Number of participants with abnormalities in clinical laboratory parameters | 48 hours |
| Berlin |
| Germany |
| D009422 | Nervous System Diseases |