PHARMACOKINETIC (PK) STUDY OF ORAL LEUPROLIDE DELIVERY WITH OVAREST® ACHIEVES DRUG LEVELS EXCEEDING THOSE OF APPROVED INJECTABLE PRODUCTS

To assess the PK profile of our oral dosage form of leuprolide (Ovarest®) as a bridge to historical data for highly effective injectable leuprolide products. Specific goals: evaluate PK profiles and dose-proportionality of single doses from 40 - 120 mg, evaluate dose-proportionality of daily dosing regimens from 80 - 120 mg/day, compare QD to BID dosing, and further quantify known food effects of Ovarest.