Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject

Inclusion Criteria:

1. Healthy adult male and female subjects, 18-45 years of age (including both ends).

2. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) withinthe range of 19 - 28 kg/m2 (including both ends).

3. During the screening period, serum creatinine is within the normal range, or thestandard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80mL/min (for female subject, according to the calculation result × 0.85）.

4. Subjects who are able to understand and give their signed informed consent beforeany trial related procedures are performed.

Exclusion Criteria:

1. Subjects who are known to be allergic to pregabalin, riluzole or any excipients ofY-4 tablets (microcrystalline cellulose, Copovidone, croscarmellose sodium,colloidal silicon dioxide, magnesium stearate and Opadry amb Ⅱ), have allergicdiseases or allergic constitution;

2. Subjects who have special requirements for diet and cannot follow the unified diet;

3. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test,urinalysis, etc.) and other screening tests found abnormalities that the researchersjudged to be of clinical significance;

4. Subjects who have experienced angioedema in the past (such as swelling of the face,mouth (tongue, lips, and gums), and neck (pharynx and throat));

5. History of dizziness or vertigo with clinical significance, or disease of inner earknown to cause dizziness or vertigo;

6. QTcF > 450 msec at the screening stage;

7. Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other seriousmental disorders, and principal investigator determines that the subject is notsuitable to participate in this trial;

8. Presence or history of hepatic or renal disease or any other condition known tointerfere with the absorption, distribution, metabolism or excretion of medicines;

9. Subjects who drink too much tea, coffee and/or caffeine-containing beverages (morethan 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, ordisagree that any caffeine-containing beverages are prohibited during the trial;

10. Subjects who have consume any diet (food or beverage) rich in grapefruit, pitaya,mango and cranberry within 14 days prior to screening;

11. Subjects have disease history or current disease that may affect the safetyevaluation of the subject or the internal process of the study drug, including thecentral nervous system, cardiovascular system, digestive system, respiratory system,urinary system, hematological system, immunology, psychiatry, metabolicabnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc. Inparticular, there is a history of dysphagia or any gastrointestinal diseaseaffecting drug absorption (including frequent nausea or vomiting caused by anycause) and eye diseases;

12. Donation or loss of blood equal to or in excess of 400 mL, or blood transfusionwithin 3 months prior to screening; or donation or loss of blood equal to or inexcess of 200 mL within 1 month prior to screening;

13. Subjects who have taken any drugs known to be strong inhibitors or inducers ofcytochrome P450 enzymes within 2 months prior to screening (such as inducers -barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors -serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem,macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones,antihistamines); or subjects who have taken any prescription drugs, over-the-counterdrugs and Chinese herbal medicine other than the above drugs within 14 days prior toscreening;

14. Subjects who have taken central nervous system (CNS) depressants including opioids (pethidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl,tramadol, etc), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam,chlordiazepine and triazolam etc), antiepileptic drugs (carbamazepine, sodiumvalproate, phenobarbital drugs etc) within 2 months prior to screening;

15. Subject with sleep apnea, or subjects with severe sleep snoring and daytimedrowsiness;

16. Subjects with suicidal thoughts and behavior;

17. Subject participated in any other clinical trials within 3 months prior toscreening;

18. Current or former drug users, or positive urine screen for drugs of abuse atscreening (screening items include: dimethylenedioxyamphetamine, methamphetamine,ketamine, morphine, tetrahydrocannabinoid acid, cocaine);

19. Alcoholics or regular drinkers within 3 months prior to screening, that is, thosewho drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mLof alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath testresults are greater than 0.0 mg/100 mL, or who cannot abstain from alcohol duringthe trial;

20. Smokers or those who cannot comply with the prohibition of smoking during the trial,or positive for cotinine screening;

21. Subjects who is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody;

22. Male subjects (or their partners) or female subjects have baby plans during thewhole trial period and within 3 months after the end of the trial, or subjects areunwilling to take one or more non-drug contraceptive measures (such as completeabstinence, condoms, ligation, etc.) during the trial period;

23. Female subjects who have unprotected intercourse within 14 days prior to screening,or pregnant or lactating women;

24. Subjects with poor compliance or other factors unsuitable for participation in thistrial.