Bioequivalence Study of Letrozole 2.5 mg Tablets

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Peratra First, Then Femara (Sequence 2)	Femara (Sequence 2)	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.
Peratra First, Then Femara (Sequence 2)	Peratra (Sequence 2)	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.
Femara First, Then Peratra (Sequence 1)	Femara (Sequence 1)	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.
Femara First, Then Peratra (Sequence 1)	Peratra (Sequence 1)	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.

Primary Outcome Measures

Name	Time	Method
Letrozole : AUC0-tz	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	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.
Letrozole : Cmax	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	Maximum Measured Concentration of Letrozole in Plasma

Secondary Outcome Measures