Actively Recruiting
A Randomized, Open-label, Single-dose, Two-period, Crossover Study Evaluating Food Effects on Y-4 Tablets in Healthy Adults
Led by Beijing Tiantan Hospital · Updated on 2025-06-10
20
Participants Needed
1
Research Sites
N/A
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 evaluating the effects of food on how the body processes a new drug called Y-4, which combines pregabalin and riluzole. This Phase 1 trial involves healthy adult men and women aged 18 to 45. The study aims to understand how a high-fat breakfast influences the absorption and behavior of Y-4 tablets in the body after a single dose. The trial is designed as a randomized, open-label, two-period crossover study with 20 participants divided into two groups. Each participant will take one Y-4 tablet containing pregabalin 112.5 mg and riluzole 28.125 mg under both fasted and fed conditions, with the order differing between groups. There is a 7-day washout period between dosing sessions, and participants will fast overnight before dosing, with water intake restricted around the drug administration. Participants will stay at the research center starting the day before drug administration. Researchers will monitor safety by tracking adverse events, lab tests, ECGs, vital signs, physical exams, blood oxygen levels, and specific scale evaluations up to about 19 days after dosing. They will also measure drug concentrations and related pharmacokinetic parameters over several days following each dose to assess how food impacts drug absorption and metabolism.
CONDITIONS
Brief 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 men and women aged 18 to 45 years
- Body weight at least 50 kg for men and 45 kg for women
- Body mass index between 19 and 28 kg/m2
- Normal serum creatinine or creatinine clearance of at least 80 mL/min
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergy to pregabalin, riluzole, or any tablet ingredients
- Special dietary needs that cannot follow the study diet
- Abnormal physical exam, vital signs, ECG, chest X-ray, or lab tests judged clinically significant
- History of angioedema or serious dizziness/vertigo
- QTcF interval above 450 msec
- Serious mental disorders such as insomnia, anxiety, depression, epilepsy
- Liver or kidney disease or conditions affecting drug processing
- High daily caffeine intake or unwillingness to avoid caffeine during the trial
- Recent consumption of grapefruit, pitaya, mango, or cranberry-rich foods
- Medical history affecting safety or drug absorption
- Recent blood donation or transfusion above specified amounts
- Recent use of certain medications affecting liver enzymes or CNS depressants
- Sleep apnea, severe snoring, daytime drowsiness
- Suicidal thoughts or behavior
- Participation in other clinical trials within 3 months
- Drug abuse history or positive drug screening
- Excessive alcohol use or inability to abstain during trial
- Smoking or inability to stop smoking during trial
- Positive test for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnancy, breastfeeding, or plans for pregnancy during and shortly after the trial
- Poor compliance or other unsuitability for participation
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 3 weeks including treatment periods and washout
Participants receive one dose of Y-4 tablet under fasted or fed conditions in two periods with a 7-day washout in between to assess the effect of food on the drug's pharmacokinetics.
2 inpatient visits for dosing separated by 7 days washout
Duration - Up to 19 days after the last dose
Participants are monitored for safety and adverse events for up to 19 days after dosing.
Multiple follow-up visits for safety assessments
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
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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