Diabetes
Conditions
Interventions
Group 1:The first group needed to complete a single-dose clinical study at a dose of 2 mg and 10 subjects, 8 of whom received the test drug and 2 received placebo, with a similar male-to-female ratio.
Group 2:A second set of tests was performed on the first set of tolerability evaluations. The second group needed to complete a single-dose clinical study at a dose of 5 mg with 10 subjects, 8 of whom
Group 3:The third set of tests was conducted with the second set of tolerability evaluable as tolerated. The third group needed to complete a single-dose clinical study at a dose of 10 mg with 10 subj
Group 4:A fourth set of tests was conducted with the third set of tolerability evaluable as tolerated. The fourth group dose of 20mg, need to complete a single administration, the impact of food on ph
Group 5:The fifth set of tests was conducted with the fourth set of tolerability evaluable as tolerated. The fifth group needed to complete a single-dose clinical study at a dose of 40 mg with 10 subj
Group 6:A sixth set of tests was conducted with the fifth set of tolerability evaluable as tolerated. The sixth group needed to complete a single-dose clinical study at a dose of 40 mg in 10 subjects,
Pre-test group:First selected 2 subjects participated in the 2mg TQ-F3083 single-dose pre-trial clinical study
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the test and fully understand the test contents, process and possible adverse reactions; 2) able to complete the study according to the requirements of the test plan; 3) Subjects (including partners) are willing to have no pregnancy plan within the next 6 months and are willing to take effective contraceptive measures voluntarily. Specific contraceptive measures are given in appendix; 4) male and female subjects aged 18-65 years (including 18 and 65 years old); 5) Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index 18 ~ 28kg / m2 range (including the critical value); 6) Health: no heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic disorders and other medical history; 7) physical examination, vital signs of normal or abnormal clinical significance.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes smoked daily during the first 3 months of the trial; 2) allergy to test drugs or their excipients, allergies (multiple drugs and food allergies); 3) A history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine); 4) Blood donation or massive blood loss (> 450 mL) within three months prior to screening; 5) Take any medication that changes liver enzyme activity 28 days prior to screening; 6) Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days prior to screening; 7) Those who have taken special diet (including dragon fruit, mango, grapefruit, etc.) or have strenuous exercise or other factors that influence the absorption, distribution, metabolism and excretion of drugs within 2 weeks before screening; 8) Inhibitors or inducers that incorporate CYP3A4, P-gp, or Bcrp such as itraconazole, ketoconazole, or dronedarone; 9) Recent changes in diet or exercise habits; 10) took the study medication within three months before taking the study medication, or participated in the drug clinical trial; 11) Have difficulty swallowing or any history of gastrointestinal diseases that affect drug absorption; 12) Any condition that increases the risk of hemorrhaging, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 13) Subjects who can not tolerate standard meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240 ml whole milk) (This applies only to participants who participated in the postprandial test Of subjects); 14) ECG abnormalities have clinical significance; 15) Female subjects are lactating or have positive pregnancy outcomes during the screening or testing phase; 16) Clinical laboratory tests and clinically significant abnormalities in chest radiography or abdominal ultrasonography, or other clinically relevant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung , Immune, mental or cardiovascular disease); 17) Viral hepatitis (including hepatitis B and C), HIV antibody, Treponema pallidum antibody screening positive. 18) Acute illness or concomitant medication from the screening stage to the study medication; 19) Chocolates, any caffeine or xanthine-rich food or drink taken 24 hours prior to taking the study drug; 20) Have taken any alcoholic product or alcohol breath test positive within 24 hours prior to taking the study medication; 21) People with positive urinalysis or who have had a history of drug abuse or who have used drugs during the past five years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Detection of insulin, C-peptide, glucagon and active GLP-1;DPP-IV enzyme activity test; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed