Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001425-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fraunhofer Institute for Translational Medicine and Pharmacology ITMP | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules.
This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood samples at different time points. To assess the safety of the administered capsules adverse events will be documented.
Analysis of lipid signaling molecules in plasma will be done to assess the role of this molecules as variable for therapeutic effects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-flurbiprofen | Experimental | 200 mg R-flurbiprofen in gelatine capsules once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-flurbiprofen | Drug | 200 mg gelatine capsule once orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) | assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication | prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration |
| Time to maximum concentration (Tmax; hours) | prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration | |
| Maximum concentration (Cmax). | prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration | |
| Terminal elimination half-life (t1/2) | prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of volunteers with serious and Non serious adverse events | Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be documented at V1 (predose and after administration) and at V3 (follow-up visit 8 to 15 days after administration of study medication) | Up to day 15 |
| Analysis of plasma lipid profile |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gerd Geisslinger, Prof MD | Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johann Wolfgang Goethe University Hospital | Frankfurt | 60528 | Germany |
Not provided
| ID | Term |
|---|---|
| C505522 | tarenflurbil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
parallel to pK-Analysis plasma lipid profile will be assessed |
| prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration |