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The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD007 10 mg | Experimental | CRD007, 10 mg tablet, single dose |
|
| CRD007 25 mg | Experimental | CRD007, 25 mg tablet, single dose |
|
| CRD007 40 mg | Experimental | CRD007, 40 mg tablet, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRD007 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - maximum plasma concentration (Cmax) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured | Pre-dose and until 12 hours post-dose |
| Pharmacokinetics - time to maximum plasma concentration (tmax) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured. | Pre-dose til 12 hours post-dose |
| Pharmacokinetics - Area under the plasma concentration curve (AUC) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured. | Pre-dose until 12 hours post-dose |
| Pharmacokinetics - elimination half life (t1/2) | Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured | pre-dose until 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Dose linearity | Evaluation of dose linearity in the dose range 10 - 40 mg | Pre-dose and until 12 hours post-dose |
| Potential for accumulation | To estimate the accumulation of CRD007 in the dose range 10 - 40 mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaj F Groendal, MD | Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery Viborg Hospital | Viborg | Denmark | 8800 | Denmark |
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| Pre-dose untill 12 hours post-dose |