Title
Bioequivalence Study of Letrozole 2.5 mg Tablets
Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
Phase
N/ALead Sponsor
Yuhan Pharmaceutical CompanyStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
letrozole ...Study Participants
26Bioequivalence
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.
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.
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.
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.
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.
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.
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.
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
| Event Type | Organ System | Event Term | Peratra | Femara |
|---|
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.
Maximum Measured Concentration of Letrozole in Plasma
