Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.
详细描述
OBJECTIVE
To evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.
MATERIAL AND METHODS
The study was approved by research Ethics Committee and all twenty-eight volunteers signed the selected IC. An open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. Twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. Plasma samples were analyzed by liquid chromatography mass spectrometry (LC-MS/MS). Statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (Cmax) and area under the curve (AUC 0-te AUC 0-inf). Analysis of variance (ANOVA) model appropriate was employed for the two periods cross under the logarithmically transformed data.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Within 10% of their ideal body weight
- •Age between 18 and 50 years
- •Healthy conditions
- •Ability to understand the written informed consent
排除标准
- •Pregnancy
- •Alcohol and drugs
研究组 & 干预措施
Metformin
500 mg
干预措施: Metformin (Drug)
Metformin
500 mg
干预措施: Glifage (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 24 hours. All adverse events observed are analyzed.
Observation of adverse events after a single dose. After administration, the volunteers need to answer the question: how are you? All complains are registered. The adverse events are going to be classified as linked ou not with the drug. The expected result is "x" volunteers presented adverse events, the most frequent was "y" event, and so one.
次要结局
未报告次要终点