Bioequivalence Study of Letrozole 2.5 mg Tablets

NCT01084499 | Completed Results

• 1 other identifier: YCD143
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bioequivalence

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Femara First, Then Peratra (Sequence 1)

EXPERIMENTAL

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); Drug: Peratra (Sequence 1)

Peratra First, Then Femara (Sequence 2)

EXPERIMENTAL

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); Drug: Peratra (Sequence 2)

Interventions

Femara (Sequence 1) 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.

Also known as: Femara Tab.[Letrozole 2.5mg]

Femara First, Then Peratra (Sequence 1)

Peratra (Sequence 1) 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.

Also known as: Peratra Tab.[Letrozole 2.5mg]

Femara First, Then Peratra (Sequence 1)

Femara (Sequence 2) 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.

Also known as: Femara Tab.[Letrozole 2.5mg]

Peratra First, Then Femara (Sequence 2)

Peratra (Sequence 2) 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.

Also known as: Peratra Tab.[Letrozole 2.5mg]

Peratra First, Then Femara (Sequence 2)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: Asan Medical Center

mdlhs@amc.seoul.kr

Study Officials

• Hyeong-seok Lim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03