Back to resultsBioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
letrozole
letrozole
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 letrozole or any comparable or similar product.
Sites / Locations
- PRACS Institute, Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
letrozole
Fermara
Arm Description
2.5 mg tablet
2.5 mg tablet
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01367626
Brief Title
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 Letrozole 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
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
letrozole
Arm Type
Active Comparator
Arm Description
2.5 mg tablet
Arm Title
Fermara
Arm Type
Active Comparator
Arm Description
2.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
letrozole
Other Intervention Name(s)
Femara
Intervention Description
2.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
letrozole
Other Intervention Name(s)
Femara
Intervention Description
2.5 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
31 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 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 letrozole or any comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan K Copa, PharmD
Organizational Affiliation
PRAC Institute, Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRACS Institute, Ltd.
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
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