Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
- Registration Number
- NCT01367626
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description letrozole letrozole 2.5 mg tablet Fermara letrozole 2.5 mg tablet
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 31 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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Trial Locations
- Locations (1)
PRACS Institute, Ltd.
🇺🇸Fargo, North Dakota, United States
PRACS Institute, Ltd.🇺🇸Fargo, North Dakota, United States