NCT01182181

Anastrozole 1 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Anastrozole 1 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anastrozole (Teva Pharmaceuticals USA)	1 mg Tablets
DRUG	Anastrozole (Arimidex®)	1 mg Tablets

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2010-08-16
• Last updated: 2010-11-15
• Results posted: 2010-11-15

Locations

1 site across 1 country: Canada