The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition.
The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.
Healthy adult male and female participants, 18-45 years of age (including both ends).
Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female participant, according to the calculation result × 0.85）
Participants who are able to understand and give their signed informed consent before any trial related procedures are performed.
Participants 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, Opadry amb Ⅱ), have allergic diseases or allergic constitution;
Participants who have special requirements for diet and cannot follow the unified diet;
Physical examinations, vital signs, 12-lead electrocardiograms (ECG), laboratory tests (Hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
Participants who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
Sequential
Y-4 tablet
DrugParticipants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4).
Pregabalin capsule
DrugParticipants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11).
Riluzole tablet
DrugParticipants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18).
Cmax
Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data;
AUC0-t
Area under the concentration-time curve from time zero to the last detectable concentration
AUC0-∞
Area under the concentration-time curve from time 0 to infinity (extrapolated).
Tmax
Time of observed Cmax, it was obtained directly from the measured plasma concentration-time data;
λz
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression;
t1/2
Terminal elimination half-life
CL/F
Apparent total body clearance
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