The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a
clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with
that of with TDT 067 under maximal use conditions.
Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are
significantly lower plasma levels of terbinafine and its major metabolites after a topical
administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil®
tablet.