Type 2 diabetes
Conditions
Interventions
Experimental group:ABP2111Na tablets administered as a single dose in dose increments of 25mg, 50mg, 100mg, 350mg, 500mg
placebo group:ABP2111Na tablets placebo single administration in dose increments of 25mg, 50mg, 100mg, 350mg, 500mg
Food Impact Study Pilot Group:ABP2111Na tablets were administered as a single 200mg dose in the first cycle in group A and crossed over in the second cycle
Food effects placebo group:ABP2111Na tablets placebo single administration of 200 mg in the first cycle and crossover administration in the second cycle in group A
Multiple dosing test group:ABP2111Na tablets were administered multiple times in dose increments of 50mg, 100mg, 200mg
Multiple administration placebo group:ABP2111Na tablets placebo multiple administrations in dose increments of 50mg, 100mg, 200mg
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1), 8 to 45 years old (including 18 and 45 years old), with appropriate gender ratio; (2), Body mass index (BMI = weight (kg)/height2 (m2)) between 18.0 and 26.0 kg/m2 (including boundary values), and male volunteers weighing =50 kg and female volunteers weighing =45 kg; (3), physical examination, vital signs, electrocardiogram, imaging, laboratory tests are normal or abnormal without clinical significance; liver and renal function requirements: alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL) = 1.0 × upper limit of normal (ULN), serum creatinine = 1.0 × ULN, or creatinine clearance > 90 mL/ min (Cockcorft-Gault formula); (4), voluntary participation and signing of the Informed Consent Form.
Exclusion criteria
Exclusion criteria: (1)History of allergy or hypersensitivity to any of the components of the product; (2) Those with the following diseases diagnosed within 6 months prior to screening, including but not limited to digestive, urinary, neuropsychiatric, hematologic, respiratory, endocrine metabolic, circulatory, infectious or neoplastic diseases; (3) Persons with clinical symptoms of hypoglycemia; (4) Persons unable to comply with a uniform diet or with swallowing disorders; (5) Persons who have used medications with weight-lowering effects (including, but not limited to, orlistat) within 3 months prior to screening; (6) Those who have used medications that may affect glucose metabolism (e.g., insulin, systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors, insulin boosters or inhibitors) within 3 months prior to screening; (7) Those who have had major surgery within 3 months prior to screening or are scheduled to undergo surgery within one month of the end of the trial; (8) Significant changes in diet/exercise habits or weight fluctuations of more than 5% in the 3 months prior to screening; (9) Smoking more than 5 cigarettes per day or ingesting an equivalent amount of nicotine or nicotine replacement in the 3 months prior to screening; (10) History of alcohol abuse within 3 months prior to screening [those who consume more than 14 units of alcohol per week (1 unit ˜ 360mL of beer or 45mL of spirits with 40% alcohol by volume or 150mL of wine)]; or those who have tested positive on an alcohol breath study at the time of screening, or at the time of admission to the hospital; (11) Participation in any other interventional clinical trial within 3 months prior to screening; (12) History of blood donation within 3 months prior to screening with = 400 mL of blood donation; (13) Anyone who has used any other medication (prescription, over-the-counter, any vitamin product or herbal remedy) within 1 month prior to screening; (14) Those who have taken a special diet (including dragon fruit, mango, grapefruit, cranberries and their juices, foods or beverages containing xanthines, caffeine, or chocolate) within 2 days prior to dosing, or who have any other factor that affects the absorption, distribution, metabolism, or excretion of drugs; (15) Persons with a positive urine drug screen prior to administration or a history of drug abuse (e.g., morphine, marijuana, methamphetamine, methylenedioxymethamphetamine, ketamine, etc.); (16) Persons who have been vaccinated within 1 month prior to screening or who plan to be vaccinated during the trial period; (17) Lactating women, and male subjects (or their partners) or female subjects who have a pregnancy plan or a sperm or egg donation plan within 30 days prior to the study and up to 6 months after the end of the study and who are unwilling to use effective contraception; and those who have a positive serum pregnancy test result during the screening period; (18)Subjects who, in the judgment of the investigator, have poor compliance or are otherwise unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac Safety;Pharmacokinetic (PK) profile;Pharmacodynamic (PD) Characterization;Food effect on PK characteristics and safety of ABP2111Na tablets; | — |
Countries
China
Contacts
Public ContactHuan Zhou
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed