Anastrozole 1 mg Tablets Under Fed Conditions
The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fed Conditions|
- Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]Bioequivalence based on Anastrozole Cmax.
- AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]Bioequivalence based on Anastrozole AUC0-t.
|Study Start Date:||September 2005|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Experimental: Investigational Test Product
Anastrozole 1 mg Tablets
1 mg Tablets
Active Comparator: Reference Listed Drug
Arimidex® 1 mg Tablets
1 mg Tablets
Other Name: Arimidex®
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
|Pharma Medica Research Inc.|
|Toronto, Ontario, Canada, M1R 5A3|
|Principal Investigator:||Xueyu (Eric) Chen, M.D., Ph.D., FRCP||Pharma Medica Research Inc.|