Single-center, Open, Randomized, Single-dose, Crossover Bioequivalence Study Evaluating the Use of the Subject Formulation, Empagliflozin And Linagliptin Tablets, Versus the Reference Formulation, Empagliflozin And Linagliptin Tablets (Glyxambi®), in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
To investigate the pharmacokinetics of the test and the reference preparation Empagliflozin And Linagliptin Tablets in healthy adult subjects by single oral administration in fasting/postprandial state, and to evaluate the bioequivalence of the two oral preparations in fasting/postprandial 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions;
- •Be able to complete the study according to the requirements of the test plan;
- •Subjects (including male subjects) agreed to have no pregnancy plan and to voluntarily take effective contraceptive measures within 3 months from the end of the study after signing the informed consent;
- •Male and female subjects aged 18 years and above;
- •Male subjects weigh at least 50kg. Female subjects weighed at least 45 kilograms. Body Mass index = weight (kg)/height 2 (m2), within the range of 19.0 to 27.0kg/m2 (including the critical value)
排除标准
- •1.History of specific allergies (urticaria, exfoliative dermatitis, angioedema or bronchial hypersensitivity), or allergies (e.g., allergy to two or more medications, foods such as milk and pollen), or known allergy to components of the drug or its analogues;
- •Those with a history of serious diseases such as cardiac, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory and mental abnormalities, etc., which are considered inappropriate by the investigating doctor;
- •Abnormalities of clinical significance as determined by the clinician, including physical examination, vital signs, electrocardiogram or clinical laboratory tests.
- •Previous or current history of pancreatitis;
- •Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2;
- •History of dysphagia or any gastrointestinal disorder that interferes with drug absorption (e.g., gastric or small bowel resection, atrophic gastritis, gastrointestinal hemorrhage, gastrointestinal bleeding);
- •Those who have difficulty in collecting blood, or cannot tolerate venipuncture, or have a history of blood or needle sickness.
- •Female subjects who are pregnant, breastfeeding or have a positive pregnancy test result;
- •Hepatitis B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody, any one or more of which is positive;
- •A history of substance abuse within five years, or drug use within three months prior to screening, or a positive urine drug screen.
- •A person who has consumed an average of more than 14 units of alcohol (1 unit = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) per week during the 3 months prior to screening, or who does not agree to stop alcohol intake 24 hours prior to check-in for each cycle until the end of the cycle for which the blood sample was collected, or who has a positive breath test for alcohol;
- •Those who smoked more than 5 cigarettes per day on average during the 3 months prior to screening or those who do not agree to stop using any tobacco products during their stay;
- •History of surgical procedure within 3 months prior to screening or planning to undergo surgery during the study;
- •Blood donation or significant blood loss within 3 months prior to the first dose, or platelet donation within 1 month for 2 treatments. Donation of 2 therapeutic doses of platelets (1 therapeutic dose = 12 U of platelets) within 1 month;
- •Participation in a clinical trial of any drug within 3 months prior to the first dose and taking the drug;
- •Use of any drug that interacts with empagliflozin and/or CYP3A4 inducers and inhibitors , P-gp substrates , etc., within 30 days prior to the screening visit；
- •Those who have taken any prescription medication within 14 days prior to taking the medication ;
- •Anyone who has taken any over-the-counter medication, herbal medicine or health product within 7 days prior to taking the medication;
- •Those who have taken special diets (e.g. grapefruit and grapefruit-containing products), or engaged in strenuous exercise, or other factors affecting the absorption, distribution, metabolism, or excretion of the drug in the 48h prior to taking the drug;
- •Those who have consumed any xanthine-rich food 48h before taking the drug;
- •Those who have special dietary requirements and are unable to comply with the diet provided by the center and the corresponding regulations;
- •Other subjects who are judged by the investigator to be unsuitable for participation. Withdrawal Criteria and Treatment
研究组 & 干预措施
Test/reference
Subjects first receive a single-dose of 25 mg/5 mg test Empagliflozin And Linagliptin tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd ) in the first treatment period and to receive the reference (R, Boehringer Ingelheim International GmbH & Co. KG )in the second treatment period.
干预措施: Test Empagliflozin And Linagliptin Tablets (Drug)
Test/reference
Subjects first receive a single-dose of 25 mg/5 mg test Empagliflozin And Linagliptin tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd ) in the first treatment period and to receive the reference (R, Boehringer Ingelheim International GmbH & Co. KG )in the second treatment period.
干预措施: Reference Empagliflozin And Linagliptin tablets (Drug)
Reference/test
Subjects first receive a single-dose of 25 mg/5 mg reference Empagliflozin And Linagliptin tablet (R, Boehringer Ingelheim International GmbH & Co. KG) in the first treatment period and to receive test tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd) in the second treatment period.
干预措施: Test Empagliflozin And Linagliptin Tablets (Drug)
Reference/test
Subjects first receive a single-dose of 25 mg/5 mg reference Empagliflozin And Linagliptin tablet (R, Boehringer Ingelheim International GmbH & Co. KG) in the first treatment period and to receive test tablet (T, produced by Qilu Pharmaceutical (Hainan) Co., Ltd) in the second treatment period.
干预措施: Reference Empagliflozin And Linagliptin tablets (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 72hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
时间窗: 72hours
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Area under the plasma concentration versus time curve (AUC0-72h)
时间窗: 72hours
Area under the drug concentration-time curve from time 0 to 72h
Area under the plasma concentration versus time curve (AUC0-∞)
时间窗: Infinite Time
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
次要结局
未报告次要终点