NCT02183571已完成1 期
Bioequivalence of Two Strengths (1000 mg and 500 mg) of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-period Crossover, Phase I Trial
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
- 56
- 主要终点
- AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females according to the following criteria: a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG) and clinical laboratory tests
- •Age ≥ 18 and Age ≤ 55 years
- •BMI ≥ 18.5 and ≤ 29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
排除标准
- •Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- •Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
- •Participation in another trial with an investigational drug within two months prior to first study drug administration
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to the start of study)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- •A history of additional risk factors for Torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •For female subjects:
- •Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
- •No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
- •Lactation
研究组 & 干预措施
Glucophage® high dose
Experimental
Part I: Treatment A + B
干预措施: BMS Glucophage® high dose (Drug)
Glucophage® low dose
Experimental
Part II: Treatment C+ D
干预措施: Merck Glucophage® low dose (Drug)
Glucophage® low dose
Experimental
Part II: Treatment C+ D
干预措施: BMS Glucophage® low dose (Drug)
Glucophage® high dose
Experimental
Part I: Treatment A + B
干预措施: Merck Glucophage® high dose (Drug)
结局指标
主要结局
AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 48 h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
时间窗: up to 48 hours after drug administration
次要结局
- AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 48 h after drug administration)
- CL/F (apparent clearance of metformin in the plasma after extravascular administration)(up to 48 h after drug administration)
- t1/2 (terminal half-life of metformin in plasma)(up to 48 h after drug administration)
- Number of patients with clinically relevant differences in physical examination(Baseline, day 1 prior, within 2-10 days following the last study drug administration)
- λz (terminal rate constant in plasma)(up to 48 h after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 48 h after drug administration)
- Number of patients with clinically relevant differences in vital signs (BP (Blood pressure), PR (Pulse rate))(Baseline, day 1 prior, within 2-10 days following the last study drug administration)
- Number of patients with clinically relevant differences in clinical laboratory tests(Baseline, day 1 prior, within 2-10 days following the last study drug administration)
- tmax (time from dosing to the maximum concentration of metformin in plasma)(up to 48 h after drug administration)
- Number of patients with clinically relevant differences in 12-lead ECG (electrocardiogram)(Baseline, day 1 prior, within 2-10 days following the last study drug administration)
- AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2)(up to 48 h after drug administration)
- MRTpo (mean residence time of metformin in the body after po administration)(up to 48 h after drug administration)
- Number of patients with adverse events(within 2- 10 after last study drug administration)
- Assessment of tolerability by investigator on a 4 point scale(within 2- 10 after last study drug administration)
研究者
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