NCT04592016 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Benfeldt E, Hansen SH, Vølund A, Menné T, Shah VP
Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method. J Invest Dermatol. 2007 Jan;127(1):170-8. Epub 2006 Jul 27.
Bodenlenz M, Aigner B, Dragatin C, Liebenberger L, Zahiragic S, Höfferer C, Birngruber T, Priedl J, Feichtner F, Schaupp L, Korsatko S, Ratzer M, Magnes C, Pieber TR, Sinner F
Clinical applicability of dOFM devices for dermal sampling. Skin Res Technol. 2013 Nov;19(4):474-83. doi: 10.1111/srt.12071. Epub 2013 Apr 13.
Bodenlenz M, Augustin T, Birngruber T, Tiffner KI, Boulgaropoulos B, Schwingenschuh S, Raney SG, Rantou E, Sinner F
Variability of Skin Pharmacokinetic Data: Insights from a Topical Bioequivalence Study Using Dermal Open Flow Microperfusion. Pharm Res. 2020 Sep 28;37(10):204. doi: 10.1007/s11095-020-02920-x.
Bodenlenz M, Tiffner KI, Raml R, Augustin T, Dragatin C, Birngruber T, Schimek D, Schwagerle G, Pieber TR, Raney SG, Kanfer I, Sinner F
Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence. Clin Pharmacokinet. 2017 Jan;56(1):91-98. doi: 10.1007/s40262-016-0442-z. Erratum in: Clin Pharmacokinet. 2017 Jan;56(1):99.
Dehghanyar P, Mayer BX, Namiranian K, Mascher H, Müller M, Brunner M
Topical skin penetration of diclofenac after single- and multiple-dose application. Int J Clin Pharmacol Ther. 2004 Jul;42(7):353-9.
Müller M, Mascher H, Kikuta C, Schäfer S, Brunner M, Dorner G, Eichler HG
Diclofenac concentrations in defined tissue layers after topical administration. Clin Pharmacol Ther. 1997 Sep;62(3):293-9.

A Single Center, Open-label, Clinical Study to Evaluate the Ability of Dermal Open Flow Microperfusion (dOFM) for Bioequivalence Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects

Details for clinical trial NCT04592016

Clinical trial NCT04592016 - References