Bioequivalence Study of Anastrozole 1 mg Tablet
The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bioequivalence Study of CJ Anastrozole 1mg Tablet and Arimidex® 1 mg Tablet|
|Study Start Date:||June 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
This study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed new generation aromatase inhibitor (CJ anastrozole) with existing anastrozole formulation (Arimidex®) in healthy Korean volunteers. This study is designed as single-dose, randomized, double-blind, 2-way crossover trial. Participants were randomized to receive 1 mg of either the CJ anastrozole or Arimidex, followed by a 3-week washout period. And then the alternate formulation was administered. After 10-hour overnight fast drug was administered. For analysis of pharmacokinetic properties, including Cmax and AUClast, blood samples were obtained at 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours after drug administration.