An Open-label, 2-arm, Single-sequence, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cmax of Dapagliflozin
研究概览
简要总结
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 50 years at the time of screening.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- •Male subjects must weigh ≥50 kg.
- •Female subjects must weigh ≥45 kg.
- •No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.
- •Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.
- •Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 50 days after the last dose, and agrees not to donate sperm or eggs during this period.
- •Able and willing to provide written informed consent after receiving a full explanation of the study.
排除标准
- •Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- •Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- •Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- •History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- •History of excessive alcohol consumption within 1 month prior to the first dose:
- •>21 drinks/week for males, >14 drinks/week for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)
- •Known hypersensitivity to any component of the investigational product.
- •Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:
- •Moderate to severe renal impairment (eGFR or creatinine clearance <45 mL/min)
- •Acute or unstable heart failure
- •Acute myocardial infarction, septicemia, or shock
- •Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis
- •Major surgery planned during the study (except minor procedures not affecting food or fluid intake)
- •Severe infections, trauma, or nutritional deficiencies
- •Positive pregnancy test or currently breastfeeding (for female subjects).
- •History of significant psychiatric illness.
- •Determined by the investigator to be unsuitable for the study for any other reason.
研究组 & 干预措施
Group A
Two-period, single-dose, crossover study
干预措施: Comparator 1 (Drug)
Group A
Two-period, single-dose, crossover study
干预措施: Comparator 2 (Drug)
Group A
Two-period, single-dose, crossover study
干预措施: Test Drug (Drug)
Group B
Two-period, single-dose, crossover study (reversed order)
干预措施: Comparator 1 (Drug)
Group B
Two-period, single-dose, crossover study (reversed order)
干预措施: Comparator 2 (Drug)
Group B
Two-period, single-dose, crossover study (reversed order)
干预措施: Test Drug (Drug)
结局指标
主要结局
Cmax of Dapagliflozin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin
AUCt of Dapagliflozin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin
Cmax of Linagliptin
时间窗: 0 hour ~ 72 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Linagliptin
AUCt of Linagliptin
时间窗: 0 hour ~ 72 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin
Cmax of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Metformin
AUCt of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
次要结局
未报告次要终点