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The study's primary objective is to determine the bioavailability of two solid formulations of IP2015 compared to a liquid formulation of IP2015 in healthy male subjects
It is planned to include 12 subjects. Each subject will take part in three treatment periods, in which they will receive a single dose of IP2015 liquid and then to different IP2015 solid formulations, respectively, in each treatment period. Overall, each subject will receive each treatment once only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP2015_PO release form 1 | Experimental | Test formulation 1 |
|
| IP2015_PO release form 2 | Experimental | Test formulation 2 |
|
| IP2015_PO release form 3 | Experimental | Test formulation 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IP2015 | Drug | Test drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Pharmacokinetics | 72 hours |
| Tmax | Pharmacokinetics | 72 hours |
| Cmax | Pharmacokinetics | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikael Thomsen, PhD | Contact | 23276134 | mt@initiatorpharma.com | |
| Claus Olesen, PhD | Contact | 61260035 | ceo@initiatorpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandy Connell, MD | MAC UK | Principal Investigator |
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