NCT05753371已完成不适用
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Geometric Mean Ratio
研究概览
简要总结
The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.
详细描述
Twenty-four subjects were given a single dose of 500 mg Metformin film-coated tablet of either formulation (test or reference) with 240 mL of a 20% glucose solution in water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Glufor® 500 mg film-coated tablet
Experimental
干预措施: Metformin Hydrochloride 500 MG (Drug)
Glucophage® 500 mg film-coated tablet
Active Comparator
干预措施: Metformin Hydrochloride 500 MG (Drug)
结局指标
主要结局
Geometric Mean Ratio
时间窗: 0-24 hours post dose
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
次要结局
- Pharmacokinetics Parameter(0-24 hours post dose)
研究者
研究点 (1)
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