Back to resultsBioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility 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 exemestane or any comparable or similar product.
Sites / Locations
- Bio-Kinetic Clinical Applications, Inc.
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01331434
Brief Title
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
AROMASIN
Intervention Description
25 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
21 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 exemestane or any comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis N Morrison, D.O.
Organizational Affiliation
Bio-Kinetic Clinical Applications, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bio-Kinetic Clinical Applications, Inc.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
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