Type 2 diabetes
Conditions
Interventions
fasting congdition:After fasting overnight for at least 10 hours, oral one tablet of the test preparation or reference preparation with 200mL 20% glucose solution on an empty stomach in the morning o
Sponsors
Nanjing First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Healthy subjects, both male and female; (2) Aged 18 and above at the time of signing the informed consent form; (3) Subjects were above 50 kg in weight,with body mass index (BMI)= body weight (kg)/ height 2(m2) in the range of 19-26 kg/m2(inclusion threshold); (4) 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, meanwhile willing and able to use medically accepted and reliable contraception during the trial; (5) Fully understanding the purpose, the nature of the test, the study procedures and possible adverse reactions, voluntarily to participate in the test and sign the informed consent form; (6) Good communication with investigators and following the requirements of the clinical study; Those who do not meet one of the above conditions shall not be selected as qualified subjects.
Exclusion criteria
Exclusion criteria: (1) With dysphagia or venous blood collection difficulties; (2) Have special requirements for diet and are not subject to a uniform diet; or are actose intolerant (has had milk-drinking diarrhea); (3) History of allergy to pioglitazone metformin, its active ingredients and excipients; clinically significant history of allergy to more than 2 foods and/or drugs; (4) Having a history of any clinical chronic or serious disease, or physical condition that may interfere with the results of the test; developing acute disease during the screening period; (5) The results of physical examination, laboratory examination, electrocardiogram, coagulation function, normal chest radiograph and vital signs examination during the screening period were judged as abnormal and clinically significant by the clinician; (6) Pregnant or lactating women (7) History of alcohol abuse or drug abuse; (8) Smoking more than 5 cigarettes per day on average within 3 months prior to administration; (9) Drinking strong tea, coffee and/or caffeinated beverages more than 1L per day within 3 months prior to administration; (10) Substance abuse or alcohol test was positive (blood alcohol content (BAC) > 0.0 mg/100 mL); (11) Participated in any clinical drug trial or equipment trial as a subject within 3 months prior to administration, or participating in other clinical trials; (12) Blood donation or pathological blood loss (?200 mL) within 3 months prior to administration, or intend to donate blood within 1 month after the trial; (13) Use any drugs that inhibit or induce the liver's metabolism, any cationic drugs secreted and excreted by renal tubules, or any prescription drugs such as nifedipine, midazolam within 30 days prior to the test; (14) Take any prescription (herbal medicines and health products) and non-prescription medicine within 14 days prior to administration; (15) Has any special diet containing grapefruit, chocolate, tea, cola, xanthine compounds or alcohol within 48 hours prior to administration, or do strenuous exercise; (16) History of drug abuse and have a positive urine drug screening; (17) Subjects considered by the investigator to have poor compliance or have any factors that make it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactFan Hongwei
Nanjing First Hospital
Outcome results
None listed