NCT00834613已完成1 期
A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Metformin ER 750 mg Tablets Versus Glucophage® XR 750 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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
- •Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening).
- •Body Mass Index (BMI - weight/height²) greater than or equal to 19 kg/m² and less than or equal to 30 kg/m².
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
- •Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.5ºC).
- •Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
- •No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
- •Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.
排除标准
- •Known history of hypersensitivity to metformin (e.g. Glucophage®) and/or related drugs such as glyburide (Diaβeta®, Euglucon®), tolbutamide (Orinase®, Apo-chlorpropamide), acetohexamide (Dimelor®), chlorpropamide (Diabinese®) and glipizide (Glucotrol®, Glibenese®).
- •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurologic, hematological, liver, or kidney disease unless judged no clinically significant by the Principal Investigator, or medical designate.
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Any clinically significant illness during the last four weeks prior to entry into this study.
- •Presence of any significant physical or organ abnormality.
- •Any subject with a history of drug abuse.
- •Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
- •Use of any prescription medication within 14 days preceding entry into this study.
- •Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
- •Female subjects: use of oral contraceptives or contraceptive implants (Such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depro-Provera®) within one year prior to drug administration.
- •Female subjects: presence of pregnancy or lactation.
- •Any subject who has had blood withdrawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- •Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- •Any subject who has donated blood within 56 days preceding this study.
- •Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
- •Significant or recent history of asthma (After 12 years of age).
- •Any subject with a recent (less than one year) history of alcohol abuse.
- •Intolerance to venipuncture.
研究组 & 干预措施
1
Experimental
干预措施: Metformin ER 750 mg Tablets (Drug)
2
Active Comparator
干预措施: Glucophage® XR 750 mg Tablets (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 36 hour period.
Bioequivalence based on Cmax.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 36 hour period.
Bioequivalence based on AUC0-inf.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 36 hour period.
Bioequivalence based on AUC0-t.
次要结局
未报告次要终点
研究者
研究点 (1)
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