Clinical trial NCT01084499: Bioequivalence Study of Letrozole 2.5 mg Tablets
Official title: Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 26
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Letrozole : AUC0-tz
timeFrame: 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
measure: Letrozole : Cmax
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Hyeong-seok Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: