Type 2 diabetes
Conditions
Interventions
fasting congdition(pre-test):After fasting overnight for at least 10 hours, oral one tablet of the test preparation or reference preparation was taken with 200mL 20% glucose solution on an empty stoma
fed condtion (pre-test):After fasting overnight for at least 10 hours, eat a high-fat and high-calorie standard meal 30 minutes before taking 1 test preparation or the reference preparation with 200mL
fasting congdition:After fasting overnight for at least 10 hours, one tablet of the test preparation or reference preparation was taken with 200mL 20% glucose solution on an empty stomach in the morni
Sponsors
NanJing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Healthy male and female; (2) Aged >=18 years; (3) Weight: above 50 kg; body mass index (BMI) = body weight (kg)/ height 2(m2) : in the range of 19-26 kg/m2(contain boundary value); (4) Vital signs, physical examination and the clinical laboratory examination were all normal or abnormal, but with no clinical significance, and the results of virology indexes were negative; (5) Subjects (including men) had no birth plan and no sperm or egg donation plan for 3 months from the screening period to the end of the study, and they were willing and able to use medically accepted and reliable contraception during the trial; (6) Volunteer to participate in the trial, maintain good communication with the investigator and comply with the requirements of the clinical trial, and obtain informed consent in accordance with the GCP.
Exclusion criteria
Exclusion criteria: (1) With dysphagia or any gastrointestinal disorder that affects drug absorption; (2) Having a history of heart, lung, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities; (3) Allergic constitution:allergic to the drug, its active ingredients and accessories; (4) Have a history of smoking, alcohol abuse or drug abuse; (5) With blood collection difficulties; (6) Blood or massive bleeding (>200 mL) was presented within 2 months prior to the trail; (7) Take any drugs (herbal medicines or health products, especially diabetes drugs) within 2 weeks prior to administration; (8) Participated in any clinical drug trial or equipment trial as a subject within 3 months prior to administration; (9) Have a positive urine drug screening; (10) Alcohol test positive (blood alcohol content (BAC) > 0.0 mg/100 mL); (11) Pregnant and lactating women; (12) Subjects considered by the investigator to have poor compliance or have any factors that make it inappropriate to participate in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactFan Hongwei
Nanjing First Hospital
Outcome results
None listed