NCT00650234已完成1 期
Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR Tablets (500 mg; Bristol-Myers Squibb) in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 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 metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 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
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years and older.
- •Sex: Male and non-pregnant, non-lactating female.
- •Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on the weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
- •Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
- •intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- •barrier methods containing or used in conjunction with a spermicidal agent, or
- •surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
- •During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
- •Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and all subjects 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, benzodiazepines, 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 vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
- •Any recent, significant change in dietary or exercise habits.
- •Positive test for any drug included in the urine drug screen.
- •Medications:
- •Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication.
- •Use of any hormonal contraceptives or hormonal replacement therapy within 3 months 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.
- •History of any significant chronic disease and/or hepatitis.
- •History of drug and/or alcohol abuse.
- •Acute illness at the time of either the pre-study medical evaluation or dosing.
- •Positive HIV, hepatitis B, or hepatitis C test.
- •Renal disease or renal dysfunction (as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL (for males) and greater than or equal to 1.4 mg/dL (for females) or abnormal creatinine clearance).
- •Abnormal and clinically significant laboratory test results:
- •Clinically significant deviation from the Guide for 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 metformin hydrochloride or other related products.
- •History of difficulty 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
Metformin Hydrochloride ER Tablets 500 mg
干预措施: Metformin Hydrochloride ER Tablets 500 mg (Drug)
2
Active Comparator
Glucophage® XR Tablets 500 mg
干预措施: Glucophage® XR Tablets 500 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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