Actively Recruiting
To Evaluate the Effect of Food on the Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Led by Beijing Tiantan Hospital · Updated on 2025-06-10
20
Participants Needed
1
Research Sites
6 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 objective is to assess the effect of food on the pharmacokinetics (PK) of pregabalin and riluzole in healthy adult subjects after a single oral dose of Y-4 tablets.
CONDITIONS
Official Title
To Evaluate the Effect of Food on the 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
- Able to understand and provide signed informed consent
You will not qualify if you...
- Allergy to pregabalin, riluzole, or any tablet ingredients
- Special diet requirements preventing adherence to study diet
- Abnormal physical exams, vital signs, ECG, chest X-ray, or lab tests judged clinically significant
- History of angioedema or clinically significant dizziness/vertigo
- QTcF interval greater than 450 msec
- Diagnosed serious mental disorders or unsuitable mental health
- Liver, kidney, or other conditions affecting drug processing
- High daily intake of caffeine-containing beverages
- Consumption of grapefruit, pitaya, mango, or cranberry within 14 days
- Medical history affecting safety 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 in past 2 months
- Use of CNS depressants including opioids, benzodiazepines, or antiepileptics in past 2 months
- Sleep apnea or severe snoring causing daytime drowsiness
- Suicidal thoughts or behaviors
- Participation in other clinical trials within 3 months
- Current or past drug abuse or positive drug screen
- Excessive alcohol use or inability to abstain during trial
- Smoking or inability to comply with smoking prohibition
- Positive for hepatitis B, hepatitis C, syphilis, or HIV antibodies
- Planning pregnancy or unwillingness to use contraception during and 3 months after trial
- Unprotected intercourse within 14 days before screening, pregnancy, or breastfeeding
- Poor compliance or other factors making participation unsuitable
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
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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