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Investigation of the bioavailability of linagliptin after concomitant multiple oral administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifampicin and Linagliptin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin | Drug |
| ||
| Linagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss) | up to 19 days | |
| Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss) | up to 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dipeptidyl-peptidase 4 (DPP-4) inhibition | up to 19 days | |
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790 | up to 19 days |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790 | up to 19 days |
| Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol | screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration |
| Aet1-t2,ss ( amount of analyte that is eliminated in urine from the time point t1 to time point t2 under steady state conditions) of linagliptin | up to 19 days |
| fet1-t2,ss ( fraction of administered drug excreted unchanged in urine at steady state over the respective time interval, where t1 and t2 define beginning and end times of the time interval) of linagliptin | up to 19 days |
| Number of patients with adverse events | up to 42 days |
| Assessment of global tolerability by investigator on a 4-point scale | up to 21 days after last drug administration |
| Number of patients with abnormal findings in physical examination | up to 21 days after last drug administration |
| Number of patients with abnormal changes in laboratory parameters | up to 21 days after last drug administration |
| Number of patients with clinically significant changes in Vital signs (Blood Pressure (BP), Pulse Rate (PR)) | up to 21 days after last drug administration |
| Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram) | up to 21 days after last drug administration |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D011799 | Quinazolines |