Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 40
- 主要终点
- Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
研究概览
简要总结
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
- •Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
- •Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
- •Blood glucose before OGTT <110 mg/dL.
- •Blood glucose 1 hour after glucose loading <180 mg/dL
- •Blood glucose 2 hours after glucose loading <140 mg/dL
排除标准
- •A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
- •Febrile illness within 1 week before drug administration
- •Family history of diabetes (within the second degree of relationship)
- •Known drug hypersensitivity or idiosyncrasy
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Habitual medication including Chinese herbal drugs
- •Intake of any drugs within 2 weeks of drug administration of period 1
- •Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
- •Donation of more than 150 mL of blood within 4 weeks before the screening examination
- •Participation in another clinical trial within 4 weeks before the screening examination
研究组 & 干预措施
Acarbose/Metformin FDC
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)
干预措施: Acarbose/Metformin FDC (BAY81-9783) (Drug)
Acarbose+Metformin
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg
干预措施: Acarbose (Glucobay, BAYG5421) (Drug)
Acarbose+Metformin
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg
干预措施: Metformin (Drug)
Acarbose
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg
干预措施: Acarbose (Glucobay, BAYG5421) (Drug)
Metformin
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg
干预措施: Metformin (Drug)
结局指标
主要结局
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
时间窗: within 4 hours after sucrose load
Cmax of metformin
时间窗: within 24 hours after dosing
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
时间窗: within 4 hours after sucrose load
AUC(0-tn) of metformin
时间窗: within 24 hours after dosing
次要结局
未报告次要终点