Actively Recruiting
Pharmacokinetics of Y-4 Tablets Compared With Pregabalin Capsules and Riluzole Tablets in Healthy Adults Under Fasted Condition
Led by Beijing Tiantan Hospital · Updated on 2025-04-20
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
N
Neurodawn Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new drug called Y-4, which combines pregabalin and riluzole, in healthy adult volunteers aged 18 to 45 years. The goal is to compare how Y-4 is processed in the body (pharmacokinetics) with the individual drugs pregabalin and riluzole taken separately. This phase 1, open-label study focuses on understanding the drug's behavior when taken after fasting. Participants will take part in three separate treatment periods with a 7-day break in between. In each period, subjects will receive a single oral dose: one Y-4 tablet containing 112.5 mg pregabalin and 28.125 mg riluzole, one pregabalin capsule (75 mg), or one riluzole tablet (50 mg). Each dose is given in a fasting state, and participants will stay at the research center for monitoring during and after dosing. During each period, blood samples will be collected for up to 72 hours to measure drug levels and monitor safety. Researchers will track adverse events, lab tests, heart activity, vital signs, physical exams, oxygen levels, and specific scales for safety up to about 25 days after dosing. Participants will be monitored closely throughout the study for any abnormal results and overall health, with the study lasting through all three dosing periods and follow-ups.
CONDITIONS
Brief Title
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males and females aged 18 to 45 years
- Body weight at least 50 kg for males and 45 kg for females
- Body mass index between 19 and 28 kg/m2
- Normal serum creatinine or creatinine clearance of at least 80 mL/min
- Able to understand and provide signed informed consent
You will not qualify if you...
- Allergy to pregabalin, riluzole, or any ingredients of Y-4 tablets
- Special dietary requirements that cannot follow the study diet
- Clinically significant abnormal physical exams, vital signs, ECG, chest X-ray, or lab tests
- History of angioedema or serious dizziness/vertigo
- QTcF greater than 450 msec
- Diagnosed serious mental disorders such as insomnia, anxiety, depression, or epilepsy
- History of liver or kidney disease or conditions affecting drug metabolism
- High caffeine intake or inability to avoid caffeine during the trial
- Consumption of grapefruit, pitaya, mango, or cranberry within 14 days before screening
- Blood donation or transfusion within specified recent periods
- Use of certain enzyme-affecting drugs or CNS depressants within defined periods before screening
- Sleep apnea, severe snoring, or daytime drowsiness
- Suicidal thoughts or behaviors
- Participation in other clinical trials within the last 3 months
- Current or past drug abuse or positive drug screening
- Excessive alcohol use or inability to abstain during the trial
- Smoking or inability to abstain from smoking during the trial
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Plans for pregnancy or unwillingness to use contraception during the study
- Recent unprotected intercourse, pregnancy, or lactation
- Poor compliance or other factors making trial participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 days with 7-day washout periods between doses
Participants receive single oral doses of three different drugs in sequence with washout periods, staying admitted for monitoring and blood sampling after each dose.
3 admission visits with overnight fasting and 72 hours of monitoring after each dosing
Duration - Up to 25 days after first dose
Participants are monitored for safety and adverse events up to about 25 days after the first drug administration.
Visits for safety evaluations as needed
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Y
Ya Shu Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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