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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
16
200 mg gelatine capsule once orally
Johann Wolfgang Goethe University Hospital
Frankfurt, Germany
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
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
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)
Time frame: Up to day 15
Analysis of plasma lipid profile
parallel to pK-Analysis plasma lipid profile will be assessed
Time frame: prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
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