Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Letrozole Tablets Under Fed Conditions
1 other identifier
interventional
28
1 country
1
Brief Summary
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Mar 2008
Shorter than P25 for phase_1 breast-cancer
1 active site
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
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedJanuary 23, 2018
January 1, 2018
1 month
June 3, 2011
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
bioequivalence determined by statistical comparison Cmax
31 days
Study Arms (2)
letrozole
ACTIVE COMPARATOR2.5 mg tablet
Fermara
ACTIVE COMPARATOR2.5 mg tablet
Interventions
Eligibility Criteria
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 letrozole or any comparable or similar product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRACS Institute, Ltd.
Fargo, North Dakota, 58104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan K Copa, PharmD
PRAC Institute, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2011
First Posted
June 7, 2011
Study Start
March 1, 2008
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
January 23, 2018
Record last verified: 2018-01