NCT07399470已完成1 期
Randomized, Open-label, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of a Triple Fixed-dose Combination Tablet (Gemigliptin/Dapagliflozin/Metformin) 50/10/1000 mg and Co-administered Zemiglo (Gemigliptin) 50 mg and Xigduo XR (Dapagliflozin/Metformin) 10/1000 mg in Healthy Adult Subjects Under Fasting Conditions
LG Chem1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年1月9日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
研究概览
简要总结
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 adults between 19 and 50 years of age
- •People with a body weight within a healthy range
- •People who do not have serious medical conditions and have been generally healthy in recent years
- •People whose screening tests (blood tests, urine tests, vital signs, ECG, etc.) show no significant abnormalities
- •Women of childbearing potential must not be pregnant at screening
- •Participants must agree to use reliable contraception or abstain from sexual activity during the study and for a short period after the last dose
- •People who fully understand the study, agree to follow study requirements, and provide written informed consent
排除标准
- •People with a history of significant diseases, such as heart, liver, kidney, lung, neurological, psychiatric, immune, or cancer-related conditions
- •People with digestive diseases or surgeries that may affect how medicines are absorbed
- •People with abnormal screening laboratory results, especially related to liver or kidney function
- •People who drink large amounts of alcohol, use drugs, or smoke heavily
- •People who have recently taken certain medications, herbal products, or dietary supplements that could interfere with the study
- •People who have recently participated in another clinical trial, donated blood, or received a blood transfusion
- •Pregnant or breastfeeding women
- •People with unstable or serious health conditions that could increase risk or affect study results
- •Anyone who, in the opinion of the study doctor, is not suitable to participate
研究组 & 干预措施
Sequence 1
Experimental
test drug > reference drug
干预措施: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Sequence 1
Experimental
test drug > reference drug
干预措施: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg (Drug)
Sequence 2
Experimental
reference drug > test drug
干预措施: Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Sequence 2
Experimental
reference drug > test drug
干预措施: Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg (Drug)
结局指标
主要结局
The plasma concentration of Gemigliptin, Dapagliflozin and Metformin
时间窗: Up to 72 hours
Area under the plasma concentration versus time curve (AUClast) of Gemigliptin, Dapagliflozin, and Metformin
次要结局
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin.(Up to 72 hours)
- The plasma concentration of Gemigliptin, Dapagliflozin and Metformin(Up to 72 hours)
研究者
研究点 (1)
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