Status:
COMPLETED
Food Effect on Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers
Lead Sponsor:
Vigonvita Life Sciences
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study is a single-center, randomized, open-label, three-period crossover design, the objective is to evaluate the pharmacokinetics and safety of VV116 tablets, which are orally administered to Ch...
Detailed Description
12 healthy subjects will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any ...
Eligibility Criteria
Inclusion
- Healthy subjects between the ages of 18 and 45 years;
- Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
- Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
- Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- 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;
Exclusion
- Subjects with hypersensitivity to VV116 or any of the excipients;
- Subjects with allergic diseases or allergic constitution;
- Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;
- Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
- Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
- Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;
- Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
- Those who cannot quit smoking or drinking during the trial;
- Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Abnormal and clinically significant chest radiographs (anteroposterior);
- B ultrasound examination showed moderate to severe fatty liver;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;
- Glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2 at screening time or baseline;
- Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) \> 450 ms in men, \> 470 ms in women, and/or other clinically significant abnormalities;
- Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05221138
Start Date
December 30 2021
End Date
January 19 2022
Last Update
February 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Xuhui Central Hospital
Shanghai, China