Diabetic neuropathy
Conditions
Interventions
Sponsors
Jiangsu Integrated Traditional Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy subjects, both male and female; 2. Age: over 18 years old (including 18 years old); 3. For the subjects with body mass index (BMI) in the range of 19.0-26.0 (including 19.0 and 26.0), BMI = weight (kg) / height 2 (M2), no less than 45kg for female and no less than 50kg for male; 4. Subjects with normal or abnormal vital signs, physical examination, laboratory examination, ECG examination and chest CT examination without clinical significance; 5. The subjects and their spouses had no family planning from the beginning of the screening period to the end of the trial within 3 months, and they were willing and able to take reliable contraceptive measures that were medically acceptable during the trial; 6. Volunteers can keep good communication with researchers and comply with the requirements of clinical trials. The process of obtaining informed consent conforms to GCP.
Exclusion criteria
Exclusion criteria: 1. The subjects with history of heart, lung, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders were not suitable to participate in the experiment; 2. Subjects who are known to be allergic to two or more kinds of drugs or food; subjects who have a history of allergy to this product and its active ingredients and excipients; subjects who have special dietary requirements and cannot follow the same dietary requirements or have dysphagia. 3. subjects with smoking history (over 5 cigarettes / day or using a large quantity of nicotine products), alcohol abuse history (drinking alcohol per week over 14 units alcohol: 1 alcohol units equal to 10mL or 8g pure alcohol, 25 mL 40% Baijiu, 330 mL 5% beer, 175mL 12% red wine, 1 1, 1.5 alcohol unit, and drug abuse history); 4. The subjects who drank too much tea, coffee or caffeinated beverage within 3 months before screening (average more than 8 cups per day, 1 cup = 250ml); 5. The subjects who consumed a large amount of grapefruit rich beverage or food (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 7 days before screening; 6. Patients with abnormal results in any of the five items of hepatitis B, hepatitis C, AIDS and syphilis and judged to be clinically significant by the researchers; 7. Subjects with difficulty in venous blood collection or patients with needle syncope and blood syncope; 8. Select the subjects who donated or lost more than 200 ml blood in the first 3 months; 9. Screening the subjects who had used various drugs in the first two weeks (including Chinese herbal medicine and health care products); 10. Subjects who have participated in other drug or device clinical trials or are participating in other clinical trials within 3 months before screening; The subjects were positive for methamphetamine, methamphetamine, methamphetamine and ketamine; 12. Subjects with positive alcohol breath test (BAC > 0.0 mg / 100 ml); 13. Pregnant and lactating women; 14. Subjects with poor compliance or with any factors unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWang Dawei
Jiangsu Integrated Traditional Chinese and Western Medicine Hospital
Outcome results
None listed