Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Status:
Completed
Trial end date:
2014-11-21
Target enrollment:
Participant gender:
Summary
This research study is being conducted to characterize the pharmacokinetic properties of a
new topical medication (MFC51123) that contains two active ingredients (diclofenac and
menthol) in two formulation packages. One formulation package is in the form of a gel in
aluminum tube and the other one in the form of a gel in roll-on applicator bottle.
Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel
and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol
gel has being developed to treat mild to moderate pain and inflammation, such as acute sport
injuries, sprains and strains. The rationale for conducting the study is to prove that
repeated topical treatment of the new diclofenac + menthol formulation in either of the two
packages does not result in unsafe systemic exposure.