NCT01155089

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2006

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

June 28, 2010

Last Update Submit

January 19, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    31 days

Interventions

AnastrozoleDRUG

1 mg tablet

Also known as: ARIMIDEX

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-Kinetic Clinical Applications

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dennis Morrison, D.O.

    Bio-Kinetic Clincial Applications

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2010

First Posted

July 1, 2010

Study Start

May 1, 2006

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)