healthy subjects
Conditions
Interventions
Sequence 1 (R-T group):In the fasting state, the reference preparation was taken orally in the first cycle, and the test preparation was taken in the second cycle, with a cleaning period of 3 days.
Sequence 2 (T-R group):In the fasting state, the test preparation was taken orally in the first cycle, and the reference preparation was taken in the second cycle, with a cleaning period of 3 days.
Sequence 3 (R-T group):In the fed state, the reference preparation was taken orally in the first cycle, and the test preparation was taken in the second cycle, with a cleaning period of 3 days.
Sequence 4 (T-R group):In the fed state, the test preparation was taken orally in the first cycle, and the reference preparation was taken in the second cycle, with a cleaning period of 3 days.
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: You can be selected only if you meet all the criteria for selection: 1).The subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the test, volunteered as subjects, and signed an informed consent form before the commencement of any research procedure, and guaranteed that I would participate in any procedure. 2).Male and female subjects aged = 18 years with appropriate sex ratio. 3).Body weight = 50.0kg for male and = 45.0 kg for female, and body mass index (BMI) is within the range of 19.0~26.0kg/m2 (including critical value). 4).Vital sign examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood coagulation function, etc.), 12-lead ECG, the results showed no abnormality or abnormality without clinical significance. 5)The subjects were able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Meeting 1 exclusion criteria means exclusion: 1).People who have a history of allergy to voglitine or any drug component have a history of allergy to two or more drugs, foods, etc. 2).Diseases that need to be excluded with abnormal clinical manifestations, including, but not limited to, systemic diseases such as nervous system, cardiovascular system (such as heart failure), digestive system (such as pancreatitis), blood and lymphoid system, immune system, kidney, liver (such as jaundice), respiratory system, metabolism and bone, skin lesions (blisters or ulcers). In particular, there are medical histories that may significantly affect the absorption, distribution, metabolism and excretion of drugs, and those related to the effects of experimental drugs. 3).Those with fasting blood glucose higher than 6.1mmol/L or lower than 3.9mmol/L; and / or those with a history of hypoglycemia / syncope. 4).Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 5).Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs. 6).Those who have used any drugs that interact with voglitine (such as thiazide diuretics, corticosteroids, thyroid hormones and sympathetic drugs) within 4 weeks before taking experimental drugs. 7).Those who have used any prescription drugs, over-the-counter drugs, Chinese herbs, vitamins and health products within 2 weeks before taking experimental drugs, have received vaccination or plan to be vaccinated during the study period. 8).People with dysphagia. 9).Those who cannot tolerate venipuncture, those who have a history of dizzy needles and blood sickness, or those who have difficulties in collecting blood in the past. 10).Screening for people with a history of drug abuse within the first 6 months. 11).Screen those who have used drugs in the first 3 months. 12).Those who smoked more than 5 cigarettes a day in the first 3 months, or could not stop using any tobacco products during the trial period. 13).Screening for those who drank more than 14 units of alcohol per week in the first 3 months (1 unit of alcohol ˜ 360mL beer or spirits or 150mL wine with 40% 45mL alcohol content), or who could not abstain from alcohol during the trial period. 14).Those who drank too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day for 3 months before taking the experimental drugs, or who could not stop using such drinks during the trial period. 15).Screen those who have participated in other drug clinical trials and taken trial drugs or have not participated in clinical trials in the first 3 months. 16).Those who donated blood within 3 months before screening, including blood components or massive blood loss (= 400mL), received blood transfusion or used blood products. 17).Hepatitis B virus surface antigen, hepatitis C antibody, HIV (1-2) antibody + p24 antigen, syphilis specific antibody (TP-ELISA) has one or more items of clinical significance. 18).Male subjects had fertility plans, were unwilling or unable to take effective contraceptive measures (Appendix 2) or had sperm donation plans within 6 months from the screening date to the last administration of the trial drug. 19).Female subjects who are breast-feeding or who have pos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Cmax;AUC0-t;AUC0-8;Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed