Bioequivalence Study of Letrozole 2.5 mg Tablets

Study Overview
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Brief Summary
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Bioequivalence

Detailed Description
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The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.

Official Title
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Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets

Conditions
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Healthy

Intervention / Treatment
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* Drug: Femara (Sequence 1)
* Drug: Peratra (Sequence 1)
* Drug: Femara (Sequence 2)
* Drug: Peratra (Sequence 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers in the age between 19 to 55 years old Subjects were neither congenital nor chronic diseases. Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form. Exclusion Criteria: Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy) Current clinically significant disorder in history taking or physical examination Acute disease within 14 days preceding the first application of study medication Had an relevant allergic disease Had history of hypersensitivity to drugs or any food Positive for Hepatitis B antigen, Hepatitis C antibody, HIV antibody, or High Quality Syphilis Reagin Test Excessive caffeine, alcohol intake and smoker(caffeine>5 units/day, alcohol>3 units/day(1 unit = pure alcohol 10ml), cigarettes> 20 cigarettes /day) Subjects who excessive alcohol intake or drug which affect drug metabolism enzyme intake within 30 days preceding study History of drug abuse or positive for urinary testing of drugs abuse (amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc.) Has donated whole blood within 60days or apheresis within 14days preceding the first application of study medication Received other investigational drug within 60days preceding the first application of study medication Taken any herbal medicine within 30days, prescription medication within 14 days or over-the-counter drug (except for vitamins, minerals) within 10days preceding the first application of study medication (might affect this study or safety of subjects as judged by the investigator) Subjects couldn't eat ASAN MEDICAL CENTER standard meal or were unsuitable for this study as judged by investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femara First, Then Peratra (Sequence 1)<br>Participants first receives a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period is separated by a 5-week washout period. | Drug: Femara (Sequence 1)<br>* Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.<br>* Other names: Femara Tab.[Letrozole 2.5mg];Drug: Peratra (Sequence 1)<br>* Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.<br>* Other names: Peratra Tab.[Letrozole 2.5mg];|
| Experimental: Peratra First, Then Femara (Sequence 2)<br>Participants first receives a generic letrozole (test - Peratra) , then a branded letrozole (reference - Femara). Each treatment period is separated by a 5-week washout period. | Drug: Femara (Sequence 2)<br>* Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.<br>* Other names: Femara Tab.[Letrozole 2.5mg];Drug: Peratra (Sequence 2)<br>* Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.<br>* Other names: Peratra Tab.[Letrozole 2.5mg];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Letrozole : AUC0-tz | Area Under the Concentration-time Curve of Letrozole in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point. | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration | 
| Letrozole : Cmax | Maximum Measured Concentration of Letrozole in Plasma | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects