Study of Food Effects of VV119 Capsules in Chinese Healthy Volunteers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVigonvita Life Sciences

About this trial

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.

Eligibility criteria

Qualifiers

Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2,

Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance,

Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential,

Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

Disqualifiers

With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial;

With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation;

With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.

With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution;

Trial design

Treatments tested in this trial

  • VV119
  • VV119

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators