Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- Letrozole : AUC0-tz
研究概览
简要总结
Bioequivalence
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Femara (Sequence 1) (Drug)
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.
干预措施: Peratra (Sequence 1) (Drug)
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.
干预措施: Femara (Sequence 2) (Drug)
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.
干预措施: Peratra (Sequence 2) (Drug)
结局指标
主要结局
Letrozole : AUC0-tz
时间窗: 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
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.
Letrozole : Cmax
时间窗: 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
Maximum Measured Concentration of Letrozole in Plasma
次要结局
未报告次要终点