NCT00648336已完成1 期
Single-Dose Fasting In Vivo Bioequivalence Study of Mercaptopurine (50 mg; Mylan) and Purinethol® Tablets (50 mg; Gate) in Healthy Male 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
- 60
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine 50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 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
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years and older.
- •Volunteers are to be sterile (documentation required) or during the course of the study, from study screen until 3 months after study exit, non-sterile male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.
- •Weight: At least 60 kg (132 lbs.) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- •All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •Use of any tobacco products within 1 year of the start of the 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 vitamin or herbal supplements within 7 days prior to the initial dose of the study medication.
- •Any recent, significant change in dietary or exercise habits.
- •History of drug and/or alcohol abuse within 1 year of the start of the study.
- •A positive result for any drug in the urine drug screen.
- •Medications:
- •Use of any medication 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 of allopurinol or aminosalicylates (e.g. olsalazine, mesalamine, sulfasalazine) within 3 months of the start of the study.
- •History of any significant chronic disease and/or hepatitis.
- •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.
- •Abnormal liver function tests (i.e. ALT (SGPT), AST (SGOT), alkaline phosphatase, bilirubin).
- •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 mercaptopurine or other related products.
- •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.
- •Family history of a deficiency in the enzyme thiopurine methyltransferase.
研究组 & 干预措施
1
Experimental
Mercaptopurine 50 mg
干预措施: Mercaptopurine 50 mg (Drug)
2
Active Comparator
Purinethol® Tablets 50 mg
干预措施: Purinethol® Tablets 50 mg (Drug)
结局指标
主要结局
Bioequivalence
时间窗: within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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