NCT00648063已完成1 期
Single-Dose Fasting Bioequivalence Study of Letrozole Tablets (2.5 mg; Mylan) and Femara® Tablets (2.5 mg; Novartis) in Healthy Postmenopausal Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
研究概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 40 years or older.
- •Sex: Females only.
- •Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
- •Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- •Baseline FSH and 17β-estradiol serum levels consistent with postmenopausal status confirmed within 72 hours of initiation of study medication (FSH greater than or equal to 40 mIU/mL; 17β-estradiol less than or equal to 31 pg/mL).
- •All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV tests, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.
- •The physical examination shall include pelvic and breast exams.
- •Pelvic findings should be consistent with hypoestrogenemia.
- •A mammogram will be required if not performed within the last 12 months.
- •A Papanicolaou ("Pap") smear will be required on subjects with an intact uterus and cervix if not performed within the last 6 months.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •Use of any tobacco-containing products within 1 year of start of study.
- •Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- •Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- •Any recent, significant change in dietary or exercise habits.
- •A positive test for any drug included in the urine drug screen.
- •History of drug and/or alcohol abuse.
- •Medications:
- •Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
- •Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- •Use hormonal replacement therapy within 3 months prior to the initial dose of study medication.
- •History of any significant chronic disease such as (but not limited to):
- •Thrombotic disorders.
- •Coronary artery or cerebrovascular disease.
- •Liver, kidney or gallbladder dysfunction/disorder(s).
- •Diabetes or any other endocrinological disease.
- •Estrogen-dependent neoplasia.
- •Postmenopausal uterine bleeding.
- •Endometrial hyperplasia.
- •Acute illness at the time of either the pre-study medical evaluation or dosing.
- •A positive HIV, Hepatitis B, or Hepatitis C test.
- •Abnormal and clinically significant laboratory test results:
- •Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- •Abnormal and clinically relevant ECG tracing.
- •Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- •Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •Allergy or hypersensitivity to letrozole, any of the inactive ingredients.
- •History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- •Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
研究组 & 干预措施
1
Experimental
Letrozole Tablets 2.5 mg
干预措施: Letrozole Tablets 2.5 mg (Drug)
2
Active Comparator
Femara® Tablets 2.5 mg
干预措施: Femara® Tablets 2.5 mg (Drug)
结局指标
主要结局
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
时间窗: Blood collections through 216 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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