Diabetic Peripheral Neuropathy Pain,DPNP and Postherpetic Neuralgia, PHN
Conditions
Interventions
Experimental group:HSK16149 (5mg/10mg/20mg/40mg/60mg/90mg/120mg)
Control group:Placebo
Sponsors
Phase I Clinical Research Centre, Shanghai Xuihui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 45 years (including 18 and 45 years of age), healthy male or female; 2) Body weight: = 50 kg for men and = 45 kg for women; BMI(body mass index) is in the range of 19 to 26 kg/m 2 (inclusive); 3) During the screening period, serum creatinine is within the range of normal values, or the clearance rate of creatinine (CCr) is more than or equal to 80 mL/min; 4) Physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (back and foreground), and important indicators of laboratory examination are normal or abnormal without clinical significance; 5) Agree that there is no parenting plan and reliable contraception measures can be taken during the trial period and within 3 months after taking the medicine; 6) Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, participate in clinical trials voluntarily and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) a person known to have a history of allergy to the research preparation and any of its components or related preparations, an allergic disorder or an allergic physique, or a history of allergy to pregabalin or gabapentin; 2) Those who have special requirements for diet and cannot comply with a unified diet; 3) Previous patients with vascular edema have occurred; 4) A history of dizziness, dizziness, or internal ear disease known to cause dizziness or dizziness, of clinical significance; 5) QTcF> 450 ms (msec) during screening; 6) insomnia, anxiety, depression or other mental disorders; 7) Use any caffeine-rich food or beverage (coffee, tea, cola, chocolate, etc.) within 48 hours before the administration of the research medicine, or disagree with the prohibition of any caffeine-rich food or beverage during the test; 8) Any history of disease or current disease that may affect the evaluation of the safety of the subject or the study of the course of the drug in vivo, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immunology, psychiatry, abnormal metabolism, gastrointestinal tract operators (except for appendicitis operations), etc.; 9) those who donate or lose more than or equal to 400 mL of blood within 3 months before drug administration or those who have blood transfusion; Those who donated blood (containing blood donation) or lost more than 200 mL of blood within 1 month before administration of the research drug; 10) Any drugs that inhibit or induce liver drug metabolizing enzymes (e.g., inducers-barbiturate, carbamazepine, phenolin, glucocorticoids, omeprazole) were used within 30 days prior to administration of the drug in the study; Inhibitors — serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines). or any prescription, over-the-counter or herbal medicine other than the aforesaid medicine is taken within 14 days prior to administration of the research medicine; 11) Those who have participated in clinical trials of other drugs within 3 months before drug administration; 12) At this stage or in the past, drug abusers or screening positive for drug abuse (screening items include: morphine, tetrahydrocannabinol, methamphetamine, dimethylenedioxam, ketamine and cocaine); 13) Alcoholics or frequent drinkers within 3 months before the test, that is, those who drink more than 21 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or those who are positive for alcohol breath test; 14) Smokers or those who smoke more than 10 cigarettes per day within 3 months before drug administration, or who cannot comply with the smoking prohibition during the test; 15) Hepatitis B surface antigen (HBG), hepatitis C virus (HBV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody positive; 16) Pregnant or lactating women; 17) Subjects considered by the researchers to have poor compliance or other unsuitable factors for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of HSK16149;The max Concentration;The Area Under Concentration;Tmax;The cumulative amount of medication discharged into feces from zero to 48 hours as a percentage of dose;The cumulative amount of medication discharged into the urine from zero to 48 hours as a percentage of the dose; | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Xuihui Central Hospital
Outcome results
None listed