NCT01388153已完成1 期
Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT Taken Without and With Water and the Glucobay Standard Tablet Following Single Oral Dosing in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 主要终点
- Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
研究概览
简要总结
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water
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
- •The informed consent must be signed before any study specific tests or procedures are done
- •Healthy male subject
- •Age: 18 to 45 years (inclusive) at the first screening examination / visit
- •Ethnicity: White
- •Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²
- •Confirmation of the subject's health insurance coverage prior to the first screening examination / visit
- •Ability to understand and follow study-related instructions
排除标准
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- •Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
- •States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
- •Fasting blood glucose level outside normal range
- •Impaired glucose tolerance in glucose tolerance test
研究组 & 干预措施
Arm 1
Experimental
干预措施: Acarbose (Glucobay ODT, BAYG5421) (Drug)
Arm 2
Experimental
干预措施: Acarbose (Glucobay ODT, BAYG5421) (Drug)
Arm 3
Active Comparator
干预措施: Acarbose (Glucobay, BAYG5421) (Drug)
结局指标
主要结局
Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
时间窗: within 4 hours after sucrose load
Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
时间窗: within 4 hours after sucrose load
次要结局
- Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)(within 4 hours after sucrose load)
- Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)(within 4 hours after sucrose load)
- Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)(within 4 hours after sucrose load)
- Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)(within 4 hours after sucrose load)
研究者
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