Diabetic Peripheral Neuropathy Pain,DPNP and Postherpetic Neuralgia, PHN
Conditions
Interventions
Experimental group:HSK16149 (15mg bid/30mg bid/45mg bid/90mg qd/60mg bid/80mg bid)
Control group:Placebo
Fed-fast group:On the morning of the first day (Phase I), a corresponding dose of HSK16149 was orally administered for 30 minutes at the beginning of a high-fat and high-calorie meal. On the morning o
Fast-fed group:On the morning of the first day (Phase I), the corresponding dose of HSK16149 was orally administered in a single dose on an empty stomach. On the morning of the fourth day (Phase II),
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 18-45 years old (including 18 and 45 years old), healthy male or female; 2) Weight: Male = 50kg, female = 45kg; Body mass index (BMI) within the range of 19-26kg/m2 (including 19 and 26); 3) During the screening period, serum creatinine was within the normal range, or the standard endogenous creatinine clearance rate (Ccr) estimated by the Cockcroft Gault formula was = 80mL/min; [Cr (mL/min)=[(140 age) × Weight (kg)]/[0.818 × Scr (µ mol/L)] (calculated as female × 0.85)]; 4) Physical examination, vital signs, 12 lead electrocardiogram (12-ECG), chest X-ray (posterior anterior position), and laboratory examination all showed normal or abnormal important indicators without clinical significance; Acceptable range of vital signs: body temperature (oral): 35.5-37.2 ?; Pulse: 50-100 beats/minute; Breathing: 12-20 times/minute; Blood pressure: systolic blood pressure is 90-139mmHg, diastolic blood pressure is 50-89mmHg; 5) Agree to have no childcare plan during the trial period and within 3 months after the last medication, and agree to use reliable contraceptive measures during this period; 6) Able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals with a known history of allergies, allergic diseases, or allergic constitution to the study formulation, any of its components, or related preparations, or individuals with a history of allergies to pregabalin or gabapentin; 2) Those who have special dietary requirements and cannot follow a unified diet; 3) Those who have experienced vascular edema in the past; 4) A history of clinically significant dizziness or dizziness, or known inner ear diseases that cause dizziness or dizziness; 5) During the screening period, it was found that QTcF>450 milliseconds (msec); 6) Insomnia, anxiety disorder, depression disorder, or other mental disorders; 7) Those who use any caffeinated food or beverage (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the study drug, or do not agree to prohibit the use of any caffeinated food or beverage during the trial period; 8) Any history or current illness that may affect the safety evaluation of the subject or the in vivo process of the study drug, including central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematology system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc; 9) Individuals who donate or lose = 400mL of blood within 3 months prior to the first administration of the investigational drug, or who receive a blood transfusion; 10) Within 30 days prior to the first administration of the investigational drug, any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors of serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) have been used, Or taking any prescription, over-the-counter, or herbal drugs other than the aforementioned drugs within 14 days prior to the administration of the study drug; 11) Those who have participated in clinical trials of other drugs within 3 months before the first administration of the study drug; 12) Current or former drug users, or those who have been screened positive for drug abuse (screening items include: morphine, tetrahydrocannabinoid acid, methamphetamine, dimethylenedioxyamphetamine, ketamine, and cocaine); 13) Alcoholics or those who frequently drink alcohol within the three months prior to the trial, i.e. those who consume more than 21 units of alcohol per week (1 unit=360mL of beer or 45mL of 40% alcohol or 150mL of wine), or those who have tested positive for alcohol breath test; 14) Smokers or those who smoke more than 10 cigarettes per day within 3 months prior to the first administration, or who are unable to comply with the ban on smoking during the trial period; 15) Positive for one or more of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, syphilis antibodies, or human immunodeficiency virus (HIV) antibodies; 16) Pregnant or lactating women; 17) Researchers believe that subjects with poor compliance or other factors that are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of HSK16149;The max Concentration;The Area Under Concentration;Tmax; | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Xuihui Central Hospital
Outcome results
None listed