A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 72
- 主要终点
- Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.
详细描述
Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations
- •Body mass index (BMI) of 18.5 to 30 kg/m(2)
- •Men and women, ages 18 to 50 years
- •Women of childbearing potential must use acceptable methods of highly effective birth control
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •History of chronic or recurrent urinary tract infection for females
- •History of glucose intolerance or diabetes mellitus
- •History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors
- •Prior exposure to Saxagliptin or Dapagliflozin or related drugs
研究组 & 干预措施
Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting
Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods
干预措施: Saxagliptin (Drug)
Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting
Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods
干预措施: Dapagliflozin (Drug)
Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting
Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
干预措施: Saxagliptin/Dapagliflozin FDC (Drug)
Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed
Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
干预措施: Saxagliptin/Dapagliflozin FDC (Drug)
Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting
Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods
干预措施: Saxagliptin (Drug)
Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting
Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods
干预措施: Dapagliflozin (Drug)
Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting
Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
干预措施: Saxagliptin/Dapagliflozin FDC (Drug)
Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed
Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
干预措施: Saxagliptin/Dapagliflozin FDC (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin
时间窗: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin
时间窗: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days
Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin
时间窗: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days
次要结局
- Cmax for 5-hydroxy (OH) Saxagliptin(54 time points up to 15 days)
- AUC(INF) for 5-hydroxy (OH) Saxagliptin(54 time points up to 15 days)
- AUC(0-T) for 5-hydroxy (OH) Saxagliptin(54 time points up to 15 days)
- Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin(54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days)
- Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results(Approximately up to 16 days)