Actively Recruiting
Study of Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Led by Vigonvita Life Sciences · Updated on 2025-12-26
16
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, randomized, open label, 2×2 crossover design to assess the standard meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
CONDITIONS
Official Title
Study of Food Effects of VV119 Capsules in Chinese Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 18 to 45 years, body weight no less than 50.0 kg
- Females aged 18 to 60 years, body weight no less than 45.0 kg, Body Mass Index between 19.0 to 26.0 kg/m2
- Medically healthy based on physical exam, vital signs, laboratory tests, and ECG with no clinically significant abnormalities
- Male subjects willing to use effective contraception during the study and for 3 months after completion; females not of child-bearing potential
- Able to understand and follow study instructions and voluntarily consent to participate
You will not qualify if you...
- History of diseases or dysfunction affecting major systems (central nervous, cardiovascular, respiratory, digestive, urinary, endocrine, blood, eyes), or history of cancer or other unsuitable diseases
- Current or past mental disorders, brain dysfunction, suicide risk, or history of self-harm
- Surgical conditions or history affecting drug absorption or excretion such as gastrointestinal surgery, urinary obstruction, gastroenteritis, ulcers, or bleeding
- Known allergy to study drug ingredients or similar drugs, or allergic diseases
- Positive tests for hepatitis B surface antigen, syphilis antibody, hepatitis C antibody, or HIV antigen/antibody
- Surgery within 3 months before screening, unrecovered surgery, or planned surgery during the trial
- Blood donation or loss ≥400 mL within 3 months or ≥200 mL within 1 month before screening, or blood product use within 3 months
- Use of any prescription, over-the-counter drugs, vitamins, or herbal products within 2 weeks before screening
- Use of drugs affecting liver enzymes CYP3A4, CYP3A5, CYP2D6 within 4 weeks before screening
- Participation in other clinical trials or use of clinical trial drugs within 3 months before screening
- Smoking more than 5 cigarettes per day, positive smoke test, or high caffeine intake within 3 months before screening
- Alcohol abuse within 1 year before screening or positive alcohol breath test
- History of drug abuse within 1 year or positive urine drug screen
- Family history of sudden cardiac death before age 40
- Resting pulse <50 or ≥100 bpm; resting blood pressure outside specified ranges; significant blood pressure drop upon standing
- Clinically significant abnormal ECG
- Elevated liver enzymes, creatinine, urea, or serum prolactin beyond normal limits
- Special dietary needs or inability to follow study diet
- Refusal to avoid smoking, alcohol, caffeine, or strenuous exercise during the trial
- Directly related to this clinical trial
- Any other condition investigator deems inappropriate for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
H
Huaqing Duan
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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