Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
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
- PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
研究概览
简要总结
Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.
详细描述
Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
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
- 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
- •Provision of signed and dated informed consent prior to any study specific procedures
- •Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive
- •Females must have a negative urine pregnancy test at screening and negative serum pregnancy test on admission to the unit, must not be lactating, and must be using an acceptable method of contraception for at least 1 month before dosing
- •Female volunteers of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year
- •Oral contraceptive and hormone replacement medications are allowed in this study if used together with a barrier contraceptive method.
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- •History or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
- •Glomerular filtration rate of less than 60 mL/min (to be estimated at screening only)
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator (eg, seasonal allergies) or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin or metformin
研究组 & 干预措施
A
5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet
干预措施: Onglyza (saxagliptin) (Drug)
A
5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet
干预措施: Diabex (Drug)
B
5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet
干预措施: Onglyza (saxagliptin) (Drug)
B
5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet
干预措施: 5-mg saxagliptin/1000 mg metformin (Drug)
C
5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet
干预措施: Diabex (Drug)
D
5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet
干预措施: 5-mg saxagliptin/500 mg metformin (Drug)
结局指标
主要结局
PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
时间窗: At day 5 to day 6 at visit 2 or 3
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
时间窗: At day 5 to day 6 at visit 2 or 3
次要结局
- Safety will be assessed by the incidence, severity, and relatedness of adverse events.(From day -1 visit 2 until performed follow up ( Approximately 30 days))
- PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)(At day 5 to day 6 at visit 2 or 3)