NCT07044765尚未招募1 期
An Open-label, 2-arm, Single-sequence, Fed, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AUCt of Metformin
研究概览
简要总结
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).
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 7 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
Experimental
Two-period, single-dose, crossover study
干预措施: Comparator 1 (Drug)
Group A
Experimental
Two-period, single-dose, crossover study
干预措施: Comparator 2 (Drug)
Group A
Experimental
Two-period, single-dose, crossover study
干预措施: Test Drug (Drug)
Group B
Experimental
Two-period, single-dose, crossover study (reversed order)
干预措施: Comparator 1 (Drug)
Group B
Experimental
Two-period, single-dose, crossover study (reversed order)
干预措施: Comparator 2 (Drug)
Group B
Experimental
Two-period, single-dose, crossover study (reversed order)
干预措施: Test Drug (Drug)
结局指标
主要结局
AUCt of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
Cmax of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Metformin
次要结局
未报告次要终点
研究者
研究点 (1)
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