S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet
Status:
Completed
Trial end date:
2020-09-24
Target enrollment:
Participant gender:
Summary
Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a
transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as
its active pharmaceutical ingredient.
The present clinical trial will be conducted to characterise maximum observed systemic
exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing 100 mg
racemic flurbiprofen in a 1:1 ratio). Characterisation will be performed under steady state
conditions in order to bridge the available safety information on the basis of the comparison
of maximum observed systemic exposure by means of AUC0-24h,ss,P vs. AUC0-24,ss,T and
Cmax,ss,P vs. Cmax,ss,T of S-flurbiprofen.