Actively Recruiting
Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Led by Beijing Tiantan Hospital · Updated on 2025-04-20
36
Participants Needed
1
Research Sites
25 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
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole. The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose. The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.
CONDITIONS
Official Title
Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult male and female subjects aged 18 to 45 years
- Body weight at least 50 kg for males and 45 kg for females
- Body mass index (BMI) between 19 and 28 kg/m2
- Normal serum creatinine or creatinine clearance of at least 80 mL/min (adjusted for females)
- Able to understand and provide signed informed consent before any study procedures
You will not qualify if you...
- Allergy to pregabalin, riluzole, or any ingredients of Y-4 tablets
- Special dietary requirements preventing adherence to study diet
- Abnormal physical exams, vital signs, ECG, chest X-ray, or laboratory tests considered clinically significant
- History of angioedema or significant dizziness/vertigo
- QTcF interval greater than 450 milliseconds at screening
- Diagnosed insomnia, anxiety, depression, epilepsy, or other serious mental disorders
- Liver or kidney disease or conditions affecting drug metabolism
- Excessive daily intake of tea, coffee, or caffeine-containing drinks (more than 8 cups)
- Consumption of grapefruit, pitaya, mango, or cranberry-rich foods or drinks within 14 days before screening
- Medical history affecting safety evaluation or drug absorption, including gastrointestinal or eye diseases
- Recent blood donation or transfusion exceeding specified amounts
- Use of strong cytochrome P450 enzyme inhibitors or inducers within 2 months before screening
- Use of central nervous system depressants including opioids, benzodiazepines, or antiepileptics within 2 months
- Sleep apnea, severe snoring, or daytime sleepiness
- Suicidal thoughts or behaviors
- Participation in another clinical trial within 3 months
- Current or past drug abuse or positive drug screening
- Alcohol abuse or inability to abstain during the trial
- Smoking or inability to abstain during the trial
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Plans for pregnancy or unwillingness to use contraception during and 3 months after the trial
- Pregnancy, breastfeeding, or unprotected intercourse within 14 days before screening
- Poor compliance or factors unsuitable for participation
AI-Screening
AI-Powered Screening
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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, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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