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The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-ORM-14540 | Active Comparator |
| |
| 14C-ORM-12741 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORM-14540 | Drug | i.v. |
| |
| ORM-12741 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables including: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs). | Before and after study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Peltonen, MD | CRST | Principal Investigator |
| Virpi Mononen | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST | Turku | Finland |
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| ID | Term |
|---|---|
| C000588919 | ORM-12741 |
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| Drug |
i.v. |
|