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
Not provided
Not provided
This is a phase 1, open-label, non-randomized, exploratory, repeated dose PK study performed at a single centre. Up to 6 evaluable subjects are planned. The subjects will receive p.o. doses of ODM-104 for 5-7 days. Single dose of paracetamol will be administered p.o. together with ODM-104 for purposes of comparison.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODM-104 and Panadol Zapp | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODM-104 | Drug | Capsule |
| |
| Paracetamol |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | In plasma / CSF | Daily PK samples during the first and last day of administration from day 1 to day 5-7 |
| Tmax | In plasma / CSF | Daily PK samples during the first and last day of administration from day 1 to day 5-7 |
| AUC | In plasma / CSF | Daily PK samples during the first and last day of administration from day 1 to day 5-7 |
| Cav | In plasma / CSF | Daily PK samples during the first and last day of administration from day 1 to day 5-7 |
| M/P ratio | In plasma / CSF | Daily PK samples during the first and last day of administration from day 1 to day 5-7 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Orion Pharma Clinical study director | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST Turku | Turku | Finland |
Not provided
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Rapidly dissolving tablet |
|
|
| Aniline Compounds |
| D000588 | Amines |