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
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