Peripheral neuropathic pain
Conditions
Interventions
Experimental group:Period 1: single oral dose of Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole)
Period 2: single oral dose of pregabalin capsule, one capsule, 75 mg/capsule
Period 3
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18~45 years old (including both ends); 2. Male weight >=50kg, female weight >=45kg, body mass index (BMI) between 19~28 kg/m2 (including both ends); 3. Serum creatinine within the normal range during the screening period, or standard endogenous creatinine clearance (CLcr) estimated by the Cockcroft-Gault formula >=80 mL/min (calculated × 0.85 for women); 4. Subjects who are able to understand and sign the informed consent form prior to any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and film coating premix (gastric solubil)), and those who have allergic diseases or allergies; 2. Those who have special requirements for diet and cannot comply with the uniform diet; 3. Those who are found to be abnormal in physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray (anteroposterior), laboratory tests (blood routine, urine routine, coagulation function, blood biochemical examination, etc.) and other screening examinations that are judged to be clinically significant; 4. Patients who are known to have had angioedema in the past (such as swelling of the face, mouth (tongue, lips and gums) and neck (pharynx and larynx)); 5. History of clinically significant dizziness or vertigo, or inner ear disease known to cause dizziness or vertigo; 6. QTcF>450 milliseconds (msec) at screening; 7. People with insomnia, anxiety disorders, depressive disorders, epilepsy or other mental disorders; 8. Has a presence or history of liver or kidney disease or any other disease known to interfere with drug absorption, distribution, metabolism, or excretion; 9. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months prior to screening, or who do not agree to prohibit the use of any caffeine-rich beverages during the trial; 10. Intake of any diet rich in grapefruit (i.e., grapefruit), dragon fruit, mango, and cranberry within 14 days before screening; 11. Have any history of disease or current illness that may affect the subject's safety evaluation or the in vivo process of the study drug, including central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (except for appendicitis surgery), etc. In particular, those with a history of dysphagia or any gastrointestinal disease that affects the absorption of the drug (including a history of frequent nausea or vomiting of any etiology) and a history of ocular disease; 12. Those who donated blood or lost blood within 3 months before screening>=400 mL, or those who had blood transfusion; or those who have donated blood or lost blood within 1 month before screening>=200 mL; 13. Use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 2 months prior to screening (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - serotonin reuptake inhibitors (SSRIs) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); or have taken any prescription drugs, over-the-counter drugs and Chinese herbal medicines other than the above drugs within 14 days before screening; 14. Subjects who have taken central nervous system (CNS) inhibitors within 2 months before screening, including opioids (meperidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl, tramadol, etc.), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam, chlordiazezepine, triazolam, etc.), anti-epileptic drugs (carbamazepine, sodium valproate, phenobarbital, etc.); 15. Subjects with a known diagnosis of sleep apnea, or subjects with sev
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and verse reactions;Maximum observed concentration;Peak time;Area under the plasma concentration-time curve from zero to the last measurable concentration;Area under the plasma concentration-time curve in time from zero to infinity;T1/2;Mean residence time from zero to the last measurable concentration;Average dwell time from zero to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Vital signs ;Hematology;Serum chemistry;Urinalysis;Coagulation test;ECG;Clinical symptom;Evaluation of C-SSRS; | — |
Countries
China
Contacts
Public ContactWang Yongjun/Li Shuya
Beijing Tiantan Hospital
Outcome results
None listed