Bioequivalence Study of Letrozole 2.5 mg Tablets

Yuhan

Status: Completed

Conditions: Healthy

Treatments: Drug: Femara (Sequence 1); Drug: Peratra (Sequence 2); Drug: Femara (Sequence 2); Drug: Peratra (Sequence 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084499

YCD143

Details and patient eligibility

About

Bioequivalence

Full description

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.

Enrollment: 26 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Femara First, Then Peratra (Sequence 1)

Experimental group

Description:

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.

Treatment:

Drug: Peratra (Sequence 1)

Drug: Femara (Sequence 1)

Peratra First, Then Femara (Sequence 2)

Experimental group

Description:

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.

Treatment:

Drug: Femara (Sequence 2)

Drug: Peratra (Sequence 2)