Diabetes
Conditions
Interventions
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Gender: Male or female; 2) Age: 18 years old or above (including 18 years old); 3) Weight: Male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be within the range of 19.0 to 26.0 kg/m2 (including boundary values); 4) Voluntarily participate and sign an informed consent form; The process of obtaining informed consent is in accordance with GCP; 5) Able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Those who have abnormalities in vital signs, physical examination, blood routine, blood biochemistry, coagulation, urine routine, 12 lead electrocardiogram, and preoperative four tests, and have been determined by the researcher to have clinical significance; 2) Liver, kidney, digestive tract (such as gastric ulcer, nausea, vomiting, stomach discomfort, heartburn, abdominal pain, bloating, diarrhea, constipation, overeating or loss of appetite, pharyngitis), skin (such as rash, eczema, itching), endocrine system, cardiovascular and cerebrovascular system (such as elevated blood pressure, heart failure, palpitations), nervous system, metabolic system, blood system (such as anemia, leukopenia or thrombocytopenia) A history of chronic or serious diseases of the respiratory system (such as sinusitis, upper respiratory tract infections), urinary system (such as urinary tract infections), and autoimmune system, or existing systemic diseases of the above systems, and determined by the researcher to be unsuitable for enrollment; 3) Individuals with a history of mental illness, drug abuse, or drug dependence; 4) Those who have special dietary requirements and cannot follow a unified diet; Or those with difficulty swallowing; 5) Allergic constitution, such as those who are allergic to two or more drugs or foods; Or known to be allergic to any component of pioglitazone and its excipients; 6) Individuals who have consumed excessive amounts (8 or more cups per day, 1 cup=250mL) of tea, coffee, or caffeinated beverages within the first 3 months of screening; Or those who consume any food or beverage containing caffeine (such as coffee, tea, chocolate, etc.) within 48 hours before administration; 7) Those who consume a large amount of grapefruit rich beverages or foods within the first 14 days of screening; Or those who have consumed any beverage or food rich in grapefruit within 48 hours before administration; 8) Difficulty in blood collection or inability to tolerate intravenous indwelling needles for blood collection or fainting or fainting; 9) Those who consume an average of more than 14 standard units of alcohol per week within the first 3 months of screening (1 standard unit contains 14g of alcohol, such as 360mL of beer or 45mL of 40% alcohol or 150mL of wine); Or those who do not agree to abstain from alcohol from the screening date until the end of the experiment; 10) Individuals who smoked = 5 cigarettes per day for the first 3 months of screening; Or those who do not agree to ban smoking from the screening date to the end of the experiment; 11) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within the first 14 days of screening; 12) Individuals who have participated in other clinical trials within the first 3 months of screening; 13) Those who have undergone surgery within the first 3 months of screening or plan to undergo surgery during the study period; And those who have undergone surgeries that may affect drug absorption, distribution, metabolism, and elimination, as determined by researchers; 14) Those who have received the vaccine within one month before screening or plan to receive the vaccine during the trial period; 15) Individuals with a history of blood donation or significant bleeding (greater than 400 mL) within 3 months prior to screening; 16) On the day of check-in, those who tested positive for drug abuse screening (morphine, tetrahydrocannabinoid acid, met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;AUC_%Extrap;?z; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed