Bioavailability of two selegiline hydrochloride tablet products.

The bioavailability of two selegiline HCl (CAS 14611-52-0) tablet products was compared in a single-blind, single-dose, randomised, two-way, cross-over study with 25 healthy volunteers. A test preparation of selegiline HCl (4 x 5 mg tablets) was compared to a reference preparation of selegiline HCI (4 x 5 mg tablets). The volunteers were randomised receiving each treatment once. Two clinic days were separated by a wash-out period of between 6 and 14 days. The variable AUC(0-∞) was the primary characteristic of the extent of formation (bioavailability) of the selegiline metabolites, desmethylselegiline and methamphetamine. For desmethylselegiline the point estimate (90 % confidence interval) of the test/reference mean ratio for the variable C max is 98.4% (91.2% to 106%), for AUC(0-∞) 103% (97.6% to 109%). and for C max /AUC(0-∞) 95.6% (89.4% to 102%). For methamphetamine the point estimate (90% confidence interval) of the test/reference mean ratio for the variable C max is 101% (96.8% to 105%), for AUC(0-∞) 102% (95.3% to 109%), and for C max /AUC(0-∞) 99.0% (91.5% to 107%). The results of this study indicate that the test preparation is bioequivalent to the reference preparation with respect to both the rate and extent of formation of desmethylselegiline and methamphetamine.