Bioequivalence Study of Letrozole 2.5 mg Tablets

NCT ID: NCT01084499

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-05-31

Brief Summary

Bioequivalence

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Femara First, Then 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.

Group Type: EXPERIMENTAL

Femara (Sequence 1)

Intervention Type: DRUG

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.

Peratra (Sequence 1)

Intervention Type: DRUG

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.

Peratra First, Then 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.

Group Type: EXPERIMENTAL

Femara (Sequence 2)

Intervention Type: DRUG

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.

Peratra (Sequence 2)

Intervention Type: DRUG

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.

Interventions

Femara (Sequence 1)

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.

Intervention Type: DRUG

Peratra (Sequence 1)

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.

Intervention Type: DRUG

Femara (Sequence 2)

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.

Intervention Type: DRUG

Peratra (Sequence 2)

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.

Intervention Type: DRUG

Other Intervention Names

Femara Tab.[Letrozole 2.5mg]; Peratra Tab.[Letrozole 2.5mg]; Femara Tab.[Letrozole 2.5mg]; Peratra Tab.[Letrozole 2.5mg]

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeong-seok Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Other Identifiers

YCD143

Identifier Type: -

Identifier Source: org_study_id