Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
研究概览
简要总结
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ages 18 to 55 inclusive
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months) gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •History of allergy or intolerance to metformin or other similar acting agents
- •Prior exposure to metformin within 3 months of study drug administration
- •Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
研究组 & 干预措施
Treatment A
500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition
干预措施: metformin (Diabex) (Drug)
Treatment B
500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition
干预措施: metformin (Glucophage™) (Drug)
Treatment C
1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition
干预措施: metformin (Diabex) (Drug)
Treatment D
1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition
干预措施: metformin (Glucophage™) (Drug)
结局指标
主要结局
Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
时间窗: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
时间窗: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
次要结局
- Participants With Abnormal Vital Sign Findings Reported as an AE(From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).)
- Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)(AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).)
- Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE(From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).)
- Participants With Abnormal Physical Findings(From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).)
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology(From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).)
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry(From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).)
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis(From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).)