Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 28
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers
详细描述
[Objectives]
- Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions
- Secondary: To evaluate safety of investigational product under fed and fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m
- •All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.
排除标准
- •History serious hypersensitivity reactions
- •History or evidence of clinically significant renal, hepatic, gastrointestinal
- •Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
- •History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period
- •History or evidence of family diabetes
- •History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
研究组 & 干预措施
fasting conditions
A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)
干预措施: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) (Drug)
fed conditions
B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)
干预措施: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast)
时间窗: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
AUC0-tlast will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞)
时间窗: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
AUC0-∞ will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
次要结局
未报告次要终点