NCT01331434

Brief Summary

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2004

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

October 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

April 6, 2011

Last Update Submit

January 19, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    21 days

Interventions

exemestaneDRUG

25 mg tablet

Also known as: AROMASIN

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
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 exemestane or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dennis N Morrison, D.O.

    Bio-Kinetic Clinical Applications, Inc.

    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

April 6, 2011

First Posted

April 8, 2011

Study Start

October 1, 2004

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)