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The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of BIBR 277 | Experimental |
| |
| Medium dose of BIBR 277 | Experimental |
| |
| High dose of BIBR 277 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of BIBR 277 | Drug |
| ||
| Medium dose of BIBR 277 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr) | Pre-dose up to 24 hours after start of treatment | |
| Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr) | Pre-dose up to 24 hours after start of treatment | |
| Maximum measured concentration of BIBR 277 in plasma (Cmax) | Pre-dose up to 24 hours after start of treatment | |
| Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax) | Pre-dose up to 24 hours after start of treatment | |
| Terminal elimination half-time of BIBR 277 in plasma (t1/2) | Pre-dose up to 24 hours after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in blood pressure (systolic, diastolic, and mean) | Pre-dose up to 14 days after start of treatment | |
| Changes from baseline in pulse rate | Pre-dose up to 14 days after start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| High dose of BIBR 277 | Drug |
|
| Number of patients with adverse events | Up to 29 days |
| Changes from baseline in laboratory test values | Pre-dose up to 14 days after start of treatment |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |