Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: BIBR1048 MS Capsule A+Pantoprazole | Experimental |
| |
| Period 1: BIBR1048 MS Capsule B+Pantoprazole | Experimental |
| |
| Period 1: BIBR1048 MS Capsule C+Pantoprazole | Experimental |
| |
| Period 1: BIBR1048 MS Capsule D+Pantoprazole | Experimental |
| |
| Period 1: BIBR1048 MS solution+Pantoprazole | Active Comparator |
| |
| Period 2: BIBR1048 MS Capsule C | Experimental |
| |
| Period 2: BIBR1048 MS Capsule D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS Capsule A | Drug |
| ||
| BIBR 1048 MS Capsule B |
| Measure | Description | Time Frame |
|---|---|---|
| Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals | up to 3 days after each administration | |
| Area under the concentration time course at steady state (AUCss) | 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of adverse events | up to 40 days | |
| Maximum plasma concentration at steady state (Cmax,ss) | 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Period 2: BIBR1048 MS solution | Active Comparator |
|
| Drug |
|
| BIBR 1048 MS Capsule C | Drug |
|
| BIBR 1048 MS Capsule D | Drug |
|
| BIBR 1048 MS tartaric acid solution | Drug |
|
| Pantoprazole | Drug |
|
| Time at which maximum plasma concentration occurs after dosing during steady state (tmax,ss) |
| 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2 |
| ID | Term |
|---|---|
| C007792 | Fumigant 93 |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided