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Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Anastrozole (Drug)

Phase: N/A

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Dennis Morrison, D.O., Principal Investigator, Affiliation: Bio-Kinetic Clincial Applications

Summary

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

Clinical Details

Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: bioequivalence determined by statistical comparison Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Bio-Kinetic Clinical Applications, Springfield, Missouri 65802, United States
Additional Information

Starting date: May 2006
Last updated: October 6, 2010

Page last updated: August 20, 2015

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