PHARMACOKINETIC (PK) STUDY OF ORAL LEUPROLIDE DELIVERY WITH OVAREST® ACHIEVES DRUG LEVELS EXCEEDING THOSE OF APPROVED INJECTABLE PRODUCTS
加药
药代动力学
药理学
医学
药品
口服剂量
作者
Gary A. Shangold,Arkady Rubin,Thomas Daggs,John Vrettos,Andrejs Rasums,Angelo Consalvo,Nicola Skeet,Sreeja Polpully Variam,Kalpana Ramakrishnan,Paul C. Shields
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.