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To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESR 1150 CL capsule | Experimental |
| |
| ESR 1150 CL ampoule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESR 1150 CL, Capsule, oral | Drug |
| ||
| ESR 1150 CL, solution, intravenous |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time zero to infinity | up to 16 hours after drug administration | |
| maximum drug plasma concentration (Cmax) | up to 16 hours after drug administration | |
| time to achieve maximum drug plasma concentration (tmax) | up to 16 hours after drug administration | |
| elimination half-life (t1/2) | up to 16 hours after drug administration | |
| mean residence time (MRT) | up to 16 hours after drug administration | |
| total clearance (CL) | up to 16 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| number of adverse events | up to day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002214 | Capsules |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Drug |
|