Diabetes
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Meet all the inclusion criteria to be selected. 1) Those who voluntarily signed the informed consent form before the trial, fully understood the content, procedure and possible adverse effects of the trial, and voluntarily participated in the trial; 2) Healthy subjects aged 18 to 65 years (including the threshold); 3) Both sexes, male weight = 50.0 kg, female weight = 45.0 kg, body mass index (BMI) in the range of 19.0~26.0 kg/m2 (including the critical value) [body mass index (BMI) = weight (kg)/height2 (m2)]; 4) Physical examination, vital signs examination, laboratory tests (routine blood, blood biochemistry, coagulation, routine urine, blood pregnancy (only for female subjects of childbearing age), transfusion IV), and electrocardiogram results that are judged by the investigator to be normal or abnormal without clinical significance; 5) Those who are able to communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria shall not be enrolled as subjects. 1) Persons with a history of endocrine, digestive, urinary, circulatory, hematologic, respiratory, motor, reproductive, or psychoneurological disorders and a history of medical conditions that may affect the absorption, distribution, metabolism, or excretion of the drug and who, in the judgment of the investigator, are not suitable for participation in this clinical trial; 2) Allergic individuals (e.g., those with allergy to two or more foods or drugs) or those with known allergy to any component of Cargolizine Tablets; 3) Those who have undergone surgery within 6 months prior to screening or during screening, or have undergone surgery that affects the absorption, distribution, metabolism, or excretion of the drug, or who are scheduled to undergo surgery during the study period; 4) Those who smoked = 5 cigarettes per day within 3 months prior to screening or during screening or who were unable to stop using any tobacco-based products from 48 h prior to the first dose until the end of the trial 5) Regular alcohol drinkers within 6 months prior to or during the screening period, i.e., those who consume more than 14 units of alcohol per week (1 unit = 357 mL of beer (5% alcohol by volume), or 43 mL of high alcohol (40% alcohol by volume), or 147 mL of wine (12% alcohol by volume)), or those who cannot stop consuming any alcohol-containing products from 48 hours prior to the first dose until the end of the trial; 6) An alcohol breath test result greater than 0.0 mg/100 mL at the time of admission; 7) who donated blood or lost a significant amount of blood = 400 mL (excluding female menstrual blood volume) within 3 months prior to screening or during the screening period, or who plan to donate blood or blood components during the trial 8) Those with a history of needle sickness or blood sickness, those who cannot tolerate venipuncture, or those who have difficulty collecting blood, or those who fail venous condition assessment; 9) Those who have participated in other clinical trials and used other drugs or test devices for clinical trials within 3 months prior to or during the screening period, or those who plan to participate in other clinical trials during this study, or those who do not come to participate in clinical trials themselves; 10) Those who have a history of substance abuse within 6 months prior to screening 11) Those who have used any medications (including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, etc.) within 14 days prior to screening or during screening, or those who have used any drugs that interact with Cagliflozin within 28 days prior to screening or during screening; 12) Those with special dietary requirements, who are unable to comply with a uniform diet or have difficulty swallowing, or who have recently undergone significant changes in dietary or exercise habits 13) Those who are lactose intolerant (those who have experienced diarrhea from drinking milk) 14) Pregnant or lactating women, or those with abnormal blood pregnancy that is judged by the investigator to be clinically significant; subjects (or their partners) who have plans to have children within 3 months of the screening date to the last dose and who do not wish to use one or more non-pharmacological contraceptive measures (e.g., total abstinence, condoms, ligation, etc.) during the trial, or subjects who have plans to donate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-8; | — |
Countries
China
Contacts
Public ContactYang Suixin
Huzhou Central Hospital
Outcome results
None listed