Actively Recruiting
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject
Led by Beijing Tiantan Hospital · Updated on 2025-04-20
10
Participants Needed
1
Research Sites
9 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 of the trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules (Lyrica®) and riluzole tablets (Rilutek®) in Chinese healthy adult subjects after single oral administration under fasted condition.
CONDITIONS
Official 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 men and women aged 18 to 45 years
- Body weight 50 kg or more for men, 45 kg or more for women
- Body mass index between 19 and 28 kg/m2
- Normal kidney function as measured by serum creatinine or creatinine clearance
- Able to understand and sign informed consent
You will not qualify if you...
- Allergy to pregabalin, riluzole, or any components of Y-4 tablets
- Special diet requirements incompatible with study diet
- Abnormal physical exam, vital signs, ECG, chest X-ray, or lab tests judged clinically significant
- History of angioedema or significant dizziness/vertigo
- QTcF longer than 450 milliseconds
- Diagnosed insomnia, anxiety, depression, epilepsy, or serious mental disorders
- Liver or kidney disease or conditions affecting drug metabolism
- High daily intake of caffeine-containing drinks or unwillingness to avoid caffeine
- Recent consumption of foods rich in grapefruit, pitaya, mango, or cranberry
- Medical conditions affecting safety or drug absorption, including gastrointestinal or eye diseases
- Recent blood donation or transfusion above set limits
- Use of certain enzyme-inducing or inhibiting drugs within 2 months
- Use of CNS depressants including opioids, benzodiazepines, or antiepileptics within 2 months
- Sleep apnea or severe snoring with daytime drowsiness
- Suicidal thoughts or behavior
- Participation in another clinical trial within 3 months
- Current or past drug abuse or positive drug screening
- Alcohol abuse or regular heavy drinking
- Smoking or inability to abstain during study
- Positive for hepatitis B, hepatitis C, syphilis, or HIV antibodies
- Planning pregnancy or unwillingness to use contraception during and 3 months after trial
- Pregnancy, breastfeeding, or unprotected sex within 14 days prior to screening
- 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
CONTACT
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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