Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)
研究概览
简要总结
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a 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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ages 19 to 45 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
- •Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- •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 to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
- •History of allergy or intolerance to metformin or other similar acting agents
- •Prior exposure to saxagliptin
- •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
Arm A
Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
干预措施: Saxagliptin (Drug)
Arm A
Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
干预措施: Metformin IR (glucophage) (Drug)
Arm B
Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
干预措施: Saxagliptin + Metformin IR (FDC) (Drug)
Arm C
Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
干预措施: Saxagliptin (Drug)
Arm C
Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
干预措施: Metformin IR (glucophage) (Drug)
Arm D
Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
干预措施: Saxagliptin + Metformin IR (FDC) (Drug)
结局指标
主要结局
Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Metformin PK Parameter Cmax
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter T-HALF
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter Tmax
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Metformin PK Parameter AUC(INF)
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
Metformin PK Parameter AUC(0-T)
时间窗: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period
Single-dose PK parameters of metformin were derived from plasma concentration versus time data.
次要结局
- BMS-510849 PK Parameter T-Half(pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period)
- BMS-510849 PK Parameter AUC(INF)(pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period)
- BMS-510849 PK Parameter AUC(0-T)(pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period)
- BMS-510849 PK Parameter Cmax(pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period)
- Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities(At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation)
- BMS-510849 PK Parameter T-Max(pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period)
- Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs(AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.)
- AEs of Special Interest(AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).)
- Number of Participants With Marked Laboratory Abnormalities (MA)(Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.)
- Number of Participants With Marked Urinalysis Abnormalities(Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.)