Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01155089
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to anastrozole or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	31 days

Trial Locations

Locations (1)

Bio-Kinetic Clinical Applications; 🇺🇸 Springfield, Missouri, United States